1. The Treatment of Obesity
Proven approaches to treating obesity and its associated co-morbidities
My name is ______________ and my background is _______________. Welcome, and thank you for participating in this presentation.
We are here today to talk about Obesity, in particular the treatment of obesity. As you look through the today’s newspapers and listen to T.V. or radio programming, the number of Americans that are overweight, obese or morbidly obese is growing. We all see it . We see it every day, in more and more of our patients.
Today we are going to talk about obesity, the co-morbid conditions associated with obesity, and treatment options that are available.
DSL#

2. This promotional education activity is brought to you by Ethicon and is not certified for continuing medical education. XXX is a paid consultant of Ethicon.

3. Presentation Topics What is obesity? Obesity treatment options
Recent clinical evidence
Obesity patient management
Here’s what we’d like to cover in todays’ presentation:
What is obesity? – looking at definitions, national trends and associated conditions
Obesity treatment options – outlining what current treatments are including the published results of each treatment type
Recent clinical evidence – there are many new studies being published on the treatment of obesity. We will have a look at some of those studies
Obesity patient management – important steps in managing the obese patient
There will be time for questions and answers at the end of the presentation.

4. What is obesity? What is obesity?
We have all heard that term before. Generally, people associate it with too much weight. While that is correct, it is only part of the picture.
The American Medical Association identified 3 criteria for a disease. They are:
An impairment of the normal functioning of some aspect of the body,
Characteristic signs or symptoms, and
Harm or morbidity.
When evaluating obesity against these criteria the conclusion is that obesity is a disease with multiple patho-physiological aspects.
What is obesity?

5. Obesity is a complex, multi-factorial, chronic metabolic disease
Obesity involves the following factors:
Genetic
Environmental
Behavioral
Psychological
Physiological
Metabolic
Obesity is a complex, multi-factorial, chronic metabolic disease, not just an excess of adipose tissue or a lack of willpower. It is a disease influenced by many interconnected factors such as genetics, environment (food availability, amount and type), behaviors (level of physical activity), psychological profile (stress management and willpower), physiology (body build and other conditions) and metabolic (metabolism and hormonal activity).
It is important in diagnosis and treatment to consider all the influencing factors.
References
1.) American Obesity Association. Fact Sheet: Obesity in the U.S. May 2,
American Obesity Association. Fact Sheet: Obesity in the U.S. May 2,

6. A contributing factor to obesity is the body’s metabolic “set point”
According to Dr. David Katz, founding director of Yale University Prevention Research Center,
"Throughout most of human history calories were scarce and hard to get, so we have numerous natural defenses against starvation… We have no defenses against overeating because we never needed them before.”
Once a person becomes obese, the body has adapted to identify this higher weight as normal, establishing and then attempting to maintain a metabolic "set point." Reduced-caloric diets and their subsequent weight loss have been shown to trigger a defensive "starvation reaction" – a cascade of hormones (such as Ghrelin) that encourages the body to regain the weight.
For obese patients, the result can be a prolonged battle with their own body regulatory mechanisms – a vicious cycle in need of intervention. This may explain why in the landmark Swedish Obese Subjects study, the control group of patients fighting obesity with diet and exercise alone (n=2037) were only able to achieve an average, sustained change in weight of less than 2%.
References
1.) Perrone M. Miracle diet pill? A safe drug prove elusive. Salt Lake Tribune 2012.
2.) Sumithran P, Prendergast, LA, Delbridge E, et al. Long-term persistence of hormonal adaptations to weight loss. N Engl J Med. 2011; 365:
3.) Carlsson LMS, Peltonen M, Ahlin S et al, Bariatric Surgery and Prevention of Type 2 Diabetes in Swedish Obese Subjects. N Engl J Med 2012; 367:
Sumithran P, Prendergast, LA, Delbridge E, et al. Long-term persistence of hormonal adaptations to weight loss.
N Engl J Med. 2011; 365:

7. Hormones play a significant role in controlling weight
Dieting Triggers Hormonal & Neuro Signals
Appetite (Ghrelin)
Satiety (PYY, CCK)
Metabolism (Leptin, Melanocortin)
Hormones play an important role in controlling weight.
Dieting triggers hormonal and neurological signals that affect an individuals’ ability to lose weight and/or keep weight lose off.
According to a Annual Review of Medicine article published in 2003, researchers found that reduced-caloric diets and subsequent weight loss triggered a cascade of hormones that encourage the body to regain weight – increasing appetite (Ghrelin), decreasing satiety (PYY/CCK), and decreasing energy expenditure (Leptin/Melanocortin).  Hormone levels still had not returned to pre-diet levels even 12 months after the diet.
The body treats a diet as the threat of starvation and, in response, enters into a defensive mode to conserve energy and restore energy-rich fat.  This is a fundamental function of the body (well-preserved throughout human evolution) to increase fat stores and survive the next period of starvation.  It’s this biological mechanism that makes it nearly impossible to lose weight by not eating.
References
) Cummings DE, Weigle DS, Frayo RS et al. Plasma ghrelin levels after diet-induced weight loss or gastric bypass surgery. N Engl J Med. 2002; 346(21):
) Cummings DE, Schwartz M. Genetics and pathyphysiology of human obesity. Annu Rev Med 2003; 54:
Cummings DE, Weigle DS, Frayo RS et al. Plasma ghrelin levels after diet-induced weight loss or gastric bypass surgery.
N Engl J Med. 2002; 346(21):
Cummings DE, Schwartz M. Genetics and pathyphysiology of human obesity. Annu Rev Med 2003; 54:

8. The National Institute of Health uses BMI to define obesity
Body mass index (BMI) is:
a measure of body fat based on height and weight.
Morbid obesity is:
a multi-factorial disease of excess fat storage (40+ BMI) and associated diseases of other systems
lifelong and progressive.
NIH Body Mass Index classifications
Between 25 and 29.9 BMI
Overweight
30 or higher BMI
Obese
40 or higher BMI
Morbidly obese
The National Institute of Health and the Center for Disease Control and Prevention currently use BMI as a measure to determine if an individual is overweight, obese or morbidly obese.
Body mass index, or BMI, is a measure of body fat based on height and weight. BMI is used because, for most people, it correlates with their amount of body fat.
With a BMI between 25 and 29.9 an individual is considered overweight. 30 or higher is considered obese. A 40 BMI or higher is considered morbidly obese.
Morbid obesity is a more severe state with associated co-morbidities. It tends to be lifelong and progressive meaning that the diseases of other systems progress over time.
References
1.) Vorvick LJ. Body Mass Index. MedlinePlus. Accessed October 9, 2012 from
Vorvick LJ. Body Mass Index. MedlinePlus. Accessed October 9, 2012 from

9. According to NIH guidelines, here is what obesity looks like*
Normal Weight (BMI 19 to 24.9)
Overweight (BMI 25 to 29.9)
Obese (Class I) (BMI 30 to 34.9)
Obese (Class II) (BMI 35 to 39.9 )
Morbidly Obese (BMI 40 or more)
With such a large percentage of our population overweight or obese, many people don’t realize they are in the overweight or obese category. A patient may realize they are morbidly obese and meet criteria for surgery, but they may be challenged by their family or even by health care professionals making a simple comment, “you don’t look like you’re that overweight.”
Let’s look at just how little an average 5’4” women would need to weigh to put her in the various categories. Here you can see examples of a lady with normal weight all the way through to morbidly obese according to the NIH classifications.
Reference
1.) Vorvick LJ. Body Mass Index. MedlinePlus. Accessed October 9, 2012 from
2.) National Heart Lung Blood Institute. Classification of Overweight and Obesity by BMI, Waist Circumference, and Associated Disease Risks. Accessed October 9, 2012 from
130 pounds
BMI 22
152 pounds
BMI 26
175 pounds
BMI 30
205 pounds
BMI 35
234 pounds
BMI 40
*For a 5’4” female
Vorvick LJ. Body Mass Index. MedlinePlus. Accessed October 9, 2012 from and National Heart Lung Blood Institute. Classification of Overweight and Obesity by BMI, Waist Circumference, and Associated Disease Risks. Accessed October 9, 2012 from 9

10. One third of the U.S. adult population is considered obese and the number is growing
% of the population that is obese by state
1990
2010
These maps depict obesity rates in the US in 1990 and 2010.
In the 1990 map, light blue indicates states with an obesity rate of less than 10%. Most states have an incidence of 10-14%, and the dark blue states are 15-19%.
In 2010, 20 years later, we see a dramatically different picture marked the first year with no “blue” states left – Colorado was surrounded for several years and in 2010, it finally tipped to 20+% obesity in the state.
Most states now have greater than 25% obesity. The national obesity average is 34% or 1/3 of US adults or 75 millions adults. Obesity doesn’t just impact individuals, it is a significant national epidemic and there are large national implications.
Reference
1.) Ogden CL, Carroll MD, Kit BK et al. Prevalence of obesity in the United States, NCHS Data Brief 2012; 82 and Centers for Disease Control and Prevention. US Obesity Trends, trends by state
No Data
< 10%
10%-14%
15%-19%
20%-24%
25%-29%
≥ 30%
75 million adult Americans are considered obese
Ogden CL, Carroll MD, Kit BK et al. Prevalence of obesity in the United States, NCHS Data Brief 2012; 82 and Centers for Disease Control and Prevention. US Obesity Trends, trends by state

11. There is a significant economic impact of obesity
$168 billion is the estimated US annual medical cost of obesity1
There is 50% higher per capita medical spending on obese patients than for normal weight individuals1
There is an 80% higher prescription drug spending for the obese patient than for normal weight individuals2
16.5% of national health expenditures are spent treating obesity- related illness1
Obesity is an expensive disease.
The economic impact of obesity is significant.
Every year an estimated $168 billion is spent on the medical cost of obesity. Interestingly, that is more than Americans spent on fast food in a year such as 2004 when they spent $140 billion.
There is a 50% higher per capita medical spending on obese patients than for normal weight individuals.
There is an 80% higher prescription drug spending than for normal weight individuals and
9.1% of the increased annual medical spending was associated with obesity.
Obesity is an expensive disease.
References
1.) Cawley, J, Meyerhoefer, C. The Medical Care Costs of Obesity: An Instrumental Variables Approach. National Bureau of Economic Research. October 2010.
2.) Finkelstein EA, Trogdon JG, Cohen JW et al. Annual medical spending attributable to obesity: Payer- and service-specific estimates. Health Affairs 2009; 28(5):w822-w831.
1. Cawley, J, Meyerhoefer, C. The Medical Care Costs of Obesity: An Instrumental Variables Approach. National Bureau of Economic Research. October Finkelstein EA, Trogdon JG, Cohen JW et al. Annual medical spending attributable to obesity: Payer- and service-specific estimates. Health Affairs 2009; 28(5):w822-w831.

12. There are significant co-morbidities associated with obesity
Pulmonary disease
abnormal PFTs
obstructive sleep apnea
hypoventilation syndrome
Nonalcoholic fatty liver disease
steatosis
steatohepatitis
cirrhosis
Cardio/Metabolic Syndrome
diabetes
dyslipidemia
hypertension
metabolic syndrome
Gynecologic abnormalities
abnormal menses
infertility
polycystic ovarian syndrome
stress incontinence
Osteoarthritis
Skin
Gallbladder disease
Cancer
breast, uterus, cervix, colon, esophagus, pancreas
kidney, prostate
Phlebitis
venous stasis
Gout
Depression
Stroke
GERD
Severe pancreatitis
Premature Death
Our bodies also pay a high price when it comes to obesity. No matter what a patient’s BMI is, almost every organ in the body is affected by excess body weight.
Let’s take a look at some of the details <Review some of the other comorbidities associated with obesity>
Regarding cancer: the New England Journal of Medicine published a study demonstrating that obesity is second only to smoking as a behavioral determinant of cancer. That is extremely powerful data.
References at end of presentation for comorbidities
Reference (cancer)
1.) Calle EE, Rodriguez C, Walker-Thurmond K. Overweight, obesity, and mortality from cancer in a prospectively studied cohort of adults. NEJM 2003; 348(17):
References at end of presentation

13. Prevalence of Significant Morbidities per Weight
As a patient’s BMI rises, so does the prevalence of co-morbid conditions
Prevalence of Significant Morbidities per Weight
As a patient’s BMI rises, so does the prevalence of co-morbid conditions. Here are some examples from a study published in Obesity in Looking particularly at the light blue column of each disease, you can see that there is a dramatic increase when a patient is morbidly obese or has a BMI of 40 or greater.
When you look at the Diabetes numbers. The incidence of Diabetes in patients with a BMI < 25 is only 4%, but look what happens when BMI increases. It shoots up to 21.5% with a BMI of > 40.
Here’s the takeaway: Weight related co-morbidities will improve with just a small amount of weight loss. And we, as medical professionals, have a responsibility to address the profound impact obesity has on our patients through medical intervention.
Conversely, there is a negative result of increasing weight that patients should be aware of.
Reference
1.) Stommel M, Schoenborn CA. Variations in BMI and prevalence of health risks in diverse racial and ethnic populations. Obesity 2010; 18(9):
Stommel M, Schoenborn CA. Variations in BMI and prevalence of health risks in diverse racial and ethnic populations. Obesity 2010; 18(9):

14. Obesity has serious consequences
Life expectancy decreases as BMI increases
For people with obesity, there is a 33% to 179% higher risk of mortality
Obesity has serious consequences.
Obesity has been directly linked to the world’s leading cause of death – cardiovascular disease – and to one of the greatest public health threats of the 21st century – diabetes.
Overweight and obesity are among the top 3 leading causes of preventable death
Obesity was associated with 112,000 additional deaths in Notice the highest peak is with the youngest patients.
Being armed with this data will assist you in having conversations with your patients.
References
1. ) Allison DB, Fontaine KR, Manson JE et al. Annual deaths attributable to obesity in the United States ; 282(16):
2. ) Fontaine KR, Redden DT, Wang C et al. Years of life lost due to obesity. JAMA 2003;289:187.
Graph represents years of life lost for white men.
Allison DB, Fontaine KR, Manson JE et al. Annual deaths attributable to obesity in the United States ; 282(16):
Fontaine KR, Redden DT, Wang C et al. Years of life lost due to obesity. JAMA 2003;289:187.

15. Obesity Treatment Options
Now that you have a better understanding of Obesity and its impact, let’s take a look at what the treatment options are that are available.
Obesity Treatment Options

16. The recommended treatment for obesity depends on the severity of the disease
The current primary treatment recommendations are based on the patient's body mass index (BMI) and the presence of one or more related co-morbidities. Generally, as obesity progresses, the recommended interventions become more aggressive.
The first treatment prescribed is usually lifestyle modification. This can involve diet, increased physical activity, or behavior modifications. Next Pharmacotherapy is prescribed – a weight loss drug and/or a disease specific treatment such as insulin for diabetes.
Finally bariatric surgery is an option presented where an individual has a BMI or 35 or greater with co-morbidities or a BMI or greater than 40.
References
1.) National Institutes of Health. The practical guide: Identification, evaluation, and treatment of overweight and obesity in adults. NIH Publication Number ; 2000.
National Institutes of Health. The practical guide: Identification, evaluation, and treatment of overweight and obesity in adults. NIH Publication Number ; 2000.

17. Lifestyle Modifications
Caloric intake should be reduced by 500 to 1,000 calories per day (kcal/day) from the current level.
Daily food logs for 4-6 weeks
Weekly weigh-in
Increased physical activity
Water intake
Behavior modification
Lifestyle modification is the foundation of any treatment option. Here are some tips you can share with your patients:
Diet: In general, diets of 1, ,200 kcal/day for women and 1, ,600 kcal/day for men should be selected. To increase the likelihood of success over time the patient should be educated about food composition, labeling, preparation, and portion size. Although dietary fat is a rich source of calories, reducing dietary fat alone without reducing calories will not produce weight loss.
Journal: Keeping a food log or journal is a great way to check the amount and type of calories consumed which helps to control the diet.
Weigh in: A weekly weigh-in, ideally at the start of a week on Monday, is usually recommended.
Exercise: Increased physical activity burns calories, reduces the risk of heart disease more than that achieved by weight loss alone, may help to reduce body fat and will help to prevent the decrease in muscle mass often found during weight loss. For the obese patient, activity should generally be increased slowly, with care taken to avoid injury.
Fluids: Water is best fluid to drink and that choice is one of the easiest ways to cut 100’s of calories a day if other beverages are typically consumed.
Behavior therapy: Talk to your patients about behavioral changes they can make to help ensure success. Specific behavioral strategy examples include self-monitoring, stress management, problem solving, contingency management, and social support.

18. Lifestyle Modifications
Comparison of weight loss/behavior programs: Atkins®, Zone, Weight Watchers®, and Ornish Diets
Type of Diet
Completing One Year
Weight Loss at One Year
Atkins®
21/40 (53%)
2.1 kg (4 lbs.)
Zone
26/40 (65%)
3.2 kg (7 lbs.)
Weight Watchers®
3.0 kg (6 lbs.)
Ornish
20/40 (50%)
3.3 kg (7 lbs.)
The research shown on this slide was a randomized trial of 160 patients with average BMI of 35 (enrollment 2000 to 2002). It was medically supervised. Each each diet reduced the LDL/HDL ratio by 10 percent. As you can see, the average amount of weight loss at one year for all diet types was less than 3.5 kgs.
According to another study, the Swedish Obesity Study, as presented in JAMA patients lost 1% with diet and lifestyle changes only.
Reference
1.) Dansinger ML, Gleason JI, Griffith JL, et al. Comparison of the Atkins, Ornish, Weight Watchers, and Zone diets for weight loss and heart disease reduction. JAMA 2005;293(1)43-53.
2.) Sjostrom L, Peltonen M, Jacobson P et al. Bariatric surgery and long-term cardiovascular events. NEJM 2012; 307(1):56-65.
According to the Swedish Obesity Study 20 year data published in JAMA, patients lost 1% with diet and lifestyle changes.
Dansinger ML, Gleason JI, Griffith JL, et al. Comparison of the Atkins, Ornish, Weight Watchers, and Zone diets for weight loss and heart disease reduction. JAMA 2005;293(1) Sjostrom L, Peltonen M, Jacobson P et al. Bariatric surgery and long-term cardiovascular events. NEJM 2012; 307(1):56-65.
Atkins is a registered trademark of Atkins Nutritionals, Inc. Weight Watchers is a registered trademark of Weight Watchers International, Inc.

19. Pharmacotherapy: Medications for Weight Loss
For patients with:
BMI ≥ 27 with co-morbidities or
BMI ≥ 30 without co-morbidities
There are 5 drugs currently available for patients.  
Alli®
Xenical®
Adipex®
Qsymia™
Belviq®
Pharmacotherapy, approved by the FDA for long-term treatment, can be a helpful adjunct for the treatment of obesity in some patients. These drugs should be used only in the context of a treatment program that includes the elements described previously—diet, physical activity changes, and behavior therapy. If lifestyle modification changes do not promote weight loss after 6 months, drugs may be considered.
There are limited FDA approved weight loss drugs on the market. The 5 currently available are – Alli, Xenical, Adipex, Qsymia and Belviq. That last two were just approved by the FDA.
Trademarks are the property of their respective owners.

20. Pharmacotherapy Xenical (orlistat)1 Alli (orlistat)2
Adipex (phentermine)3
Qsymia (phentermine/topiramate extended release)
Belviq (lorcaserin hydrocholride)
Mechanism of action
Blocks fat absorption
Induces satiety
Reduced appetite & possible satiety enhancement
Reduced appetite & feel fuller sooner
Dosage
120 mg TID
60 mg TID
15 – 37.5 mg QD
3.75 mg/23 mg QD for 14 days, then increase to 7.5 mg/46 mg QD. Dose may be titrated higher if WL not achieved after 12 weeks
10 mg BID
Average weight Loss
5.7 lbs at 1 year
5 – 10 lbs at 6 months
7.92 lbs at 1 year
5.1%-10.9% of body weight at 1 year
5.8% of body weight at 1 year
Concerns
GI symptoms, risk of liver damage
GI symptoms risk of liver damage
Monitor blood pressure
Monitor heart rate
Possible risk of cardiac event
The decision to add a drug to an obesity treatment program should be made after consideration of all potential risks and benefits and only after all behavioral options have been exhausted.
Orlistat - Xenical is the prescription version of Orlistate and Alli is the over the counter version. Orlistat blocks absorption of ~30% dietary fat. 1/3 of the fat passes undigested which can result in GI side effects.  Results show that there were approximately 5.7 pounds of weight loss at 1 year. Alli is sold over the counter at half the dose of Xenical, and blocks about 15% of fat from being absorbed. Approximate weight loss is 5-10 pounds at 6 months. Orlistate and Allli both carry risks of GI symptoms and liver damage
Phentermine has been around the longest, was one ½ of the drug phen-fen. Generally prescribed mg twice daily with results of approximately 8 pounds weight loss at 1 year.
Qsymia and Belviz are new weight loss drugs recently securing FDA approval. Both work to reduce appetite.
References
1.) Xenical Prescribing Information. 2.) Alli product label. 3. ) ePocrates–Adipex-P monograph; Li Z, MaglioneM, TuW et al. Meta-analysis: Pharmacologic Treatment of Obesity. Ann Intern Med. 2005;142: )Qsymia Pirescribing Information 5. ) Belviq Prescribing Information.
Xenical Prescribing Information Alli product label. 3. ePocrates–Adipex-P monograph; Li Z, MaglioneM, TuW et al. Meta-analysis: Pharmacologic Treatment of Obesity. Ann Intern Med. 2005;142:
4. Qsymia Pirescribing Information 5. Belviq Prescribing Information.

21. Bariatric & Metabolic Surgery:
For patients with:
BMI ≥ 35 with co-morbidities or
BMI ≥ 40 without co-morbidities
Provides medically significant sustained weight loss
Involves alteration of the GI tract that affects cellular and molecular signaling and leads to a physiologic improvement in energy balance, nutrient utilization, and metabolic disorders.
Examined in many clinical studies for effects on weight and co- morbidities
Weight loss surgery is an option for weight reduction in patients with clinical obesity, i.e. a BMI ≥40, or a BMI ≥ 35 with co-morbid conditions. Weight loss surgery provides medically significant sustained weight loss for more than 5 years in many patients.
An integrated program that provides guidance on diet, physical activity, and psychosocial concerns before and after surgery is necessary. Most patients fare remarkably well with reversal of diabetes, control of hypertension, marked improvement in mobility, return of fertility, cure of pseudo tumor cerebri, and significant improvement in quality of life.
Late complications are uncommon.
References
1.) National Institutes of Health. The practical guide: Identification, evaluation, and treatment of overweight and obesity in adults. NIH Publication Number ; 2000.

22. Comparison of surgical treatment options
Excess
Weight Loss
Laparoscopic Adjustable Gastric Banding1
41%
Sleeve Gastrectomy2
66%
Gastric Bypass Surgery3
62%
So given the possible treatment options, it is interesting to see the actual weight loss %’s that clinical studies have identified. By far, bariatric surgery provides the greatest excess weight loss with a greater than 45% 1 year+ surgery compared to a 10% or less for lifestyle and/or pharmacological treatments.
References
1. ) Phillips E, Ponce J, Cunneen SA, et al. Safety and effectiveness of REALIZE® adjustable gastric band: 3-year prospective study in the United States. Surg Obes Rel Dis. 2009; 5: P<0.001
2. ) Fischer L, Hildebrandt C, Bruckner T, Kenngott H, Linke GR, Gehrig T, Büchler MW, Müller-Stich BP. Excessive weight loss after sleeve gastrectomy: a systematic review. Obes Surg May;22(5):
3. ) O’Brien PE, McPhail T, Chaston TB, et al. Systematic review of medium-term weight loss after bariatric operations. Obes Surg. 2006; 16(8):
Surgery is Currently the Most Effective Treatment for Morbid Obesity
Average Weight Loss from baseline; meta-analysis of various studies up to 4 years in length.
1. Phillips E, Ponce J, Cunneen SA, et al. Safety and effectiveness of REALIZE® adjustable gastric band: 3-year prospective study in the United States. Surg Obes Rel Dis. 2009; 5: P<0.001
2. Fischer L, Hildebrandt C, Bruckner T, Kenngott H, Linke GR, Gehrig T, Büchler MW, Müller-Stich BP. Excessive weight loss after sleeve gastrectomy: a systematic review. Obes Surg May;22(5):
3. O’Brien PE, McPhail T, Chaston TB, et al. Systematic review of medium-term weight loss after bariatric operations. Obes Surg. 2006; 16(8):

23. Major medical societies are advocating for bariatric surgery
“It is clear that obesity surgery today offers the only effective long-term treatment option for the severely obese patient.”
- American Heart Association (AHA), 2011
“Bariatric surgery should be considered for adults with BMI ≥ 35 kg/m2 and type 2 diabetes, especially if the diabetes is difficult to control with lifestyle and pharmacologic therapy.”
- ADA “The Standards of Medical Care in Diabetes,” 2009
“Weight-loss surgery is the most effective treatment for morbid obesity producing durable weight loss, improvement or remission of co-morbid conditions, and longer life.”
- Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), 2009
Bariatric surgery is recognized by many professional organization as the most effective treatment for morbid obesity. In fact many leading associations in the US have developed position statements supporting bariatric surgery for certain patients, including…
the American Heart Association… the American Diabetes Association…and the Society of American Gastrointestinal and Endoscopic Surgeons.
Standards of care -- as outlined by these associations -- clearly point to surgical intervention in the treatment of severe obesity and related co-morbidities for appropriate patients.
We’ve seen that surgery is the most effective treatment option, and many prominent societies agree. But, what are we actually doing about it?
References
1. ) Poirer P, Cornier M-A, Mazzone T. Bariatric surgery and cardiovascular risk factors: A scientific statement from the American Heart Association.Circulation 2011;123: l
2. ) American Diabetes Association.  Standards of medical care in diabetes –  Diabetes Care 2009; 32 (S1): S13-S61
3. ) SAGES Guidelines Committee. SAGES guideline for clinical application of laparoscopic bariatric surgery. Surg Endosc 2008 Oct;22(10):
1 Poirer.P, Cornier M-A, Mazzone T. Bariatric surgery and cardiovascular risk factors: A scientific statement from the American Heart Association.Circulation 2011;123: l
2 American Diabetes Association.  Standards of medical care in diabetes –  Diabetes Care 2009; 32 (S1): S13-S61
3 SAGES Guidelines Committee. SAGES guideline for clinical application of laparoscopic bariatric surgery.
Surg Endosc 2008 Oct;22(10):

24. Treatments Prescribed for Morbid Obesity
Even though we have much evidence that surgery is currently the most effective treatment for morbid obesity… healthcare providers, rarely recommend it.
A study published in SOARD (Surgery for Obesity and Related Diseases) Journal in 2007 provided the results of surveys given to 478 experienced physicians from 6 specialty areas where attitudes and practices regarding the treatment of patients with morbid obesity were evaluated. Despite the fact that bariatric surgery is the most effective treatment option for severe obesity with regard to sustained weight loss, providers surveyed in this study prescribed it on the average of only 15% of the time for their morbidly obese patients.
References
1. ) Avidor Y, Still CD, Brunner M, et al. Primary care and subspecialty management of morbid obesity: referral patterns for bariatric surgery. Surg Obes Relat Dis. 2007;3(3):
Avidor Y, Still CD, Brunner M, et al. Primary care and subspecialty management of morbid obesity: referral patterns for bariatric surgery. Surg Obes Relat Dis. 2007;3(3):

25. Continuum of care for the obese patient
All of the treatments described have a role to play with the Bariatric patient. During the course of their disease they may see many Healthcare Professionals ranging from family physicians to specialists to a bariatric surgeon. It is important to understand the benefits and risks associated with each treatment, as well as the likelihood of long term success.
As we have discussed previously, diet, exercise, and behavior modification as treatment modalities for the morbid obesity patient that have been shown in general that they do not produce long term weight loss that move patients to a more healthier BMI range. However, these treatment methods were prescribed most commonly by many of the surveyed specialty providers.
In the spectrum of care, it is important to find the right treatment for the right time in the patients disease progression. While there are 245,000 procedures done each year of which 90% are laparoscopic, bariatric surgery only represents about 1% of the bariatric surgery eligible patient population.
References
1. ) Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide Obes Surg 2009; 19:
There are many healthcare professionals that must work together to identify the right time for the right treatment.
.* From Janssen 25

26. Surgical Options for Obesity Treatment
Here’s a look at some of the Surgical Options that are available to treat Obesity.
Surgical Options for Obesity Treatment

27. Bariatric Surgery Procedure Types
A laparoscopic approach for bariatric surgery is performed ~90% of the time.
Bariatric surgery procedures can be open, with a surgical incision, or laproscopic. Today, 90%+ of bariatric procedures are performed laproscopically.
References
1. ) Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide Obes Surg 2009; 19:
Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide Obes Surg 2009; 19:

28. Bariatric surgery – most common procedures
Roux-en-Y Gastric Bypass
Sleeve Gastrectomy
Adjustable Gastric Banding
Bypass a portion of the small intestine and create a cc stomach pouch
Re-sect approximately three-fourths of the stomach
Place implantable device around upper most part of stomach
The 3 most common bariatric procedures performed today are the Gastric Bypass, Sleeve Gastrectomy and Gastric Band.
The Gastric Bypass is the current Gold Standard procedure for weight loss surgery. It represents the largest volume of all procedures performed in the US. This procedure bypasses a portion of the small intestine to create a 15-30cc stomach pouch.
A growing procedure in the US is the sleeve gastrectomy. With the sleeve gastrectomy approximately three-fourths of the stomach is re-sected.
Laparoscopic Adjustable Gastric Banding is also performed in the US. In this procedure, a silicone band is placed around the upper most part of the stomach. The band can be adjusted to vary the degree of restriction.
References
1. ) Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide Obes Surg 2009; 19:
~245,000 procedures annually (US)

29. Comparing the benefits and risks of bariatric surgery
Given the strong excess weight loss results, why are there less procedures happening?
Let’s have a look at the benefits and risks of bariatric surgery.
Comparing the benefits and risks of bariatric surgery

30. There are significant co-morbidity improvements associated with bariatric surgery
Depression*
47% reduced
Obstructive sleep apnea
45% to 76% resolved
Migraines*
46% improved
Diabetes
25% to 66% controlled
Hypertension
42% to 66% resolved
Asthma
39% improved
Urinary stress incontinence*
50% resolved
As you can see on the slide, bariatric surgery may provide a significant reduction and/or resolution of co-morbidities. Let’s take a look at some of the specific examples.
Diabetes is resolved for 25 – 66% of patients.
Hypertension is resolved for 42% - 66% of patients.
Osteoarthritis or joint disease is resolved for 41% of patients and
Obstructive sleep apnea is resolved for 45% to 76% of patients.
References at end of presentation
Nonalcoholic fatty liver disease
37% resolution of steatosis
Osteoarthritis* /Degenerative joint disease
41% resolved
References at end of presentation. * Study population predominantly female.

31. 90-Day Adverse Event Rates by Procedure*
*When performed at a Bariatric Surgery Center of Excellence
You may not know this, but every Bariatric Surgery Center of Excellence must report their outcomes data to a national registry.
This chart shows the breakdown of serious events and mortality rates by procedure from this national registry – you will see that there are over 70,000 patients in this study (patients had surgery between June 2007 and September 2009). The % of serious events following all 3 types of bariatric surgery was below 2%. The % of mortality was less that .25%.
Overall, regardless of procedure, you can see the complications are exceptionally low.
References
1. ) SRC BOLD Report: Summary of Key Statistics Prepared for SRC’s Strategic Alliance Partners. March Data is reported on 80,157 research-consented patients who have had a surgery entered in BOLD from June 2007 through Sept 22, All patients with data in BOLD have had their bariatric surgery performed by a surgeon participating in SRC’s Bariatric Surgery Center of Excellence (BSCOE) program.
Serious events include death, anastomotic leakage, cardiac arrest, deep vein thrombosis, evisceration, heart failure, liver failure, multi-system organ failure, myocardial infarction, pneumothorax, pulmonary embolism, renal failure, respiratory failure, sepsis, stroke, systemic inflammatory response syndrome, and bleeding requiring blood transfusion. Does not include non-serious events such as nausea/vomiting, dehydration, and atelectasis.
SRC BOLD Report: Summary of Key Statistics Prepared for SRC’s Strategic Alliance Partners. March Data is reported on 80,157 research-consented patients who have had a surgery entered in BOLD from June 2007 through Sept 22, All patients with data in BOLD have had their bariatric surgery performed by a surgeon participating in SRC’s Bariatric Surgery Center of Excellence (BSCOE) program.

32. CMS: Inpatient Discharge Data (2010) Morbidity & mortality rates of gastric bypass are similar to other common procedures
In fact the mortality rate has been shown to be lower than with other common procedures such as a laproscopic cholesectomy, hip replacement or CABG.
While there are risks with any surgery, Bariatric Surgery is portrayed in the media as extremely risky, with the mortality rate often erroneously cited as approximately 1%.
Over the years, bariatric surgery has progressively become safer for these reasons:
advances in the procedures and techniques
the fact that 90% or more are now performed lapraoscopically, and
3. the institution of Center of Excellence Accreditation.
The mortality rate is .13%. This is the accurate data you should be using to inform your patients.
References
) Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide Obes Surg 2009; 19:
) Direct Research, LLC, Center for Medicare and Medicaid Services, FY 2010 MedPAR, Medicare Fee-for-Service Inpatient Discharges with Selected Procedures
Source: Direct Research, LLC, Center for Medicare and Medicaid Services, FY 2010 MedPAR, Medicare Fee-for-Service Inpatient Discharges with Selected Procedures

33. Bariatric Surgery: Benefits vs. Risks
Highest level of excess weight loss
Co-morbidity resolution or reduction
Reduction in mortality
Risks:
General risks of surgery
Band erosion / slippage / leak / malfunction
Esophageal spasm/reflux or esophageal/stomach inflammation
Gastric perforation
Outlet obstruction
Clinical studies show that the benefits of Bariatric surgery are strong relating to excess weight loss and resolution or reduction of co-morbidities.
Additionally, mortality is improved moving from .7% with surgery to 6.2% without surgery. That compares favorably to heart surgery at 8% mortality rate with surgery and 17% without.
The risks associated with Bariatric surgery include any risks typically associated with surgery. These may include conditions such as: Anastomotic/staple line leak, bowel obstruction, cholecystitis, chronic anemia, fistula, internal hernia, intestinal irritation, nutritional deficiencies, osteoporosis, or pancreatitis.
Additionally, there are risks particular to bariatric surgery that could include band erosion, slippage, leak or malfunction for a gastric band procedure; esophageal spasm, reflux, inflamation for other bariatric procedures.
References
1. ) Direct Research, LLC, Center for Medicare and Medicaid Services, FY 2010 MedPAR, Medicare Fee-for-Service Inpatient Discharges with Selected Procedures
Note: Lists are not exhaustive. Risks are in addition to the general risks of surgery. Patient weight, age and medical history play a significant role in determining specific risks.

34. Recent Clinical Evidence Bariatric Surgery and Medication Usage
Recently there have been a large number of significant clinical study findings reported that investigate the merits of bariatric surgery compared to other obesity treatments. We will now have a look at some of the most significant study results.
Recent Clinical Evidence Bariatric Surgery and Medication Usage

35. STAMPEDE
Surgical treatment and medications achieved glycemic control in more patients than medical therapy alone.
The STAMPEDE study published Year 1 results in the New England Journal of Medicine --- March, 2012 issue. The most significant finding from that study was that surgical treatment and medications achieved glycemic control in more patients than medical therapy alone.
STAMPEDE is a single site, prospective, randomized controlled trial conducted at the Cleveland Clinic with 150 patients. The study compares the efficacy of three treatments for patients with T2DM and BMI between kg/m2 that are:
Intensive Medical Therapy*
Intensive Medical Therapy* + Laparoscopic Sleeve Gastrectomy
Intensive Medical Therapy* + Gastric Bypass
The primary endpoint of the study is the proportion of patients with a glycated hemoglobin level of 6.0% or less at 12 months after treatment.
References
1. ) Schauer PR, Kashyap SR, Wolski K, et al. Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes. N Engl J Med. 2012; 366:
Schauer PR, Kashyap SR, Wolski K, et al. Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes. N Engl J Med. 2012; 366:
Study supported by a grant from Ethicon.

36. STAMPEDE results
Surgical treatment and medications achieved glycemic control of HbA1c < 6.0% in more patients than medical therapy alone
Significantly more diabetic patients achieved glycemic control following bariatric surgery * **
The results show that significantly more diabetic patients were at glycemic control – measured by HbA1c < 6.0% with or without diabetes medications 12 months after being randomly placed into one of the legs of the study that had bariatric surgery.
According to the article published in the New England Journal of Medicine:
“In obese patients with uncontrolled type 2 diabetes, 12 months of medical therapy plus bariatric surgery achieved glycemic control in significantly more patients than medical therapy alone.”
12% of those that had medical therapy alone were in glycemic control compared to 42% who had medical therapy and gastric bypass and 37% who had medical therapy and sleeve gastrectomy.
References
1. ) Schauer PR, Kashyap SR, Wolski K, et al. Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes. N Engl J Med. 2012; 366:
Medical Therapy
Medical Therapy + Gastric Bypass
*p=0.002
Medical Therapy + Sleeve Gastrectomy
**p=0.008
Glycemic control: HbA1c < 6.0% with or without diabetes medications, 12 mo after randomization. Figures adapted from study data.

37. STAMPEDE results
Surgical treatment and medications achieved glycemic control of HbA1c < 7.0% in more patients than medical therapy alone
Significantly more diabetic patients achieved glycemic control following bariatric surgery * * **
The results show that significantly more diabetic patients were at glycemic control – measured by HbA1c < 7.0% with or without diabetes medications 12 months after being randomly placed into one of the legs of the study that had bariatric surgery.
0% of those that had medical therapy alone were in glycemic control compared to 68% who had medical therapy and gastric bypass and 45% who had medical therapy and sleeve gastrectomy.
References
1. ) Schauer PR, Kashyap SR, Wolski K, et al. Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes. N Engl J Med. 2012; 366:
Medical Therapy
Medical Therapy + Gastric Bypass
*p<0.001
Medical Therapy + Sleeve Gastrectomy
**p<0.001
Glycemic control: HbA1c < 7.0% without diabetes medications, 12 mo after randomization. Figures adapted from study data.

38. Medical Therapy + Gastric Bypass Medical Therapy + Sleeve Gastrectomy
STAMPEDE results
Patients following bariatric surgery experienced:
Significant decreases in diabetic medication usage
Significantly lower average HbA1c levels
Significantly greater weight loss than medical therapy alone
Medical Therapy
Medical Therapy + Gastric Bypass
Medical Therapy + Sleeve Gastrectomy
Mean % Weight Loss
5.2%
27.5%*
p<0.001
24.7%*
Mean % Excess Weight Lost
13%
88%*
81%*
Additional findings from the study include a significant decrease in diabetic medication usage, significantly lower average levels of HbA1c and significantly greater weight loss with those patients that had bariatric surgery and medical therapy compared to those with medical therapy alone.
“Mean levels of glycated hemoglobin and fasting plasma glucose were significantly lower in each of the two surgical groups than in the medical therapy group”(p<0.001).
The average number of diabetic medications per patient per day tended to increase in the medical therapy group but decreased significantly in each surgical group (p<0.001)
Greater than 50% of patients in each surgical group used NO diabetes medications at 12 months.
Additional findings were that there were no episodes of serious hypoglycemia and only 4 instances where the patient required re-operation to address adverse events – gallstones, self-limited bleeding, nausea/vomiting and gastric leak.
References
1. ) Schauer PR, Kashyap SR, Wolski K, et al. Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes. N Engl J Med. 2012; 366:
Of note, the average BMI was 36, with 34% of patients with a BMI < 35.

39. Mingrone
Bariatric surgery resulted in better glucose control than did medical therapy
The Mingrone study was a single center study with 60 patients in 3 arms. Results from the Mingrone study were published in the New England Journal of Medicine in April, The chief conclusion from the study was that Bariatric surgery resulted in better glucose control than did medical therapy alone.
References
1. ) Mingrone, G, et. al. Bariatric Surgery versus Conventional Medical Therapy for Type 2 Diabetes, N Engl J Med 2012, March 26, [Epub ahead of print]
Mingrone, G, et. al. Bariatric Surgery versus Conventional Medical Therapy for Type 2 Diabetes, N Engl J Med 2012, March 26, [Epub ahead of print]

40. Mingrone – Results Glycated Hemoglobin Levels during 2 Years of Follow-up
Here you can see the results of medical therapy compared to gastric bypass and biliopancreatic diversion. Both bariatric procedures reduced the glycated Hemoglobin score versus medical therapy.
References
1. ) Mingrone, G, et. al. Bariatric Surgery versus Conventional Medical Therapy for Type 2 Diabetes, N Engl J Med 2012, March 26, [Epub ahead of print]
Mingrone, G, et. al. Bariatric Surgery versus Conventional Medical Therapy for Type 2 Diabetes, N Engl J Med 2012, March 26, [Epub ahead of print]

41. Buchwald (systematic review)
T2DM resolved or improved in 87% of patients following bariatric surgery
The Buchwald study was a systemtic review and meta-analysis conducted in It found that T2DM was resolved or improved in 87% of patients following bariatric surgery.
Reference
1. ) Buchwald H, Estok R, Farbach K, et al. Weight and Type 2 Diabetes after Bariatric Surgery: Systematic Review and Meta-analysis. Am J Med. 2009;122(3):

42. Buchwald: Systematic Review & Meta-Analysis (2009) T2DM resolved or improved in 87% of patients following bariatric surgery
99%
87%
87%
85%
81%
Total
The study reviewed 621 studies which included 135,246 patients. Overall, T2DM 87% resolved or improved (78% resolved) for patients after bariatric surgery. Specifically 81% with gastric banding, 87% with gastroplasty, 85% with gastric bypass and 99% with BPD/DS.
References
1. ) Buchwald H, Estok R, Farbach K, et al. Weight and Type 2 Diabetes after Bariatric Surgery: Systematic Review and Meta-analysis. Am J Med. 2009;122(3): Figure adapted from source data. Data included includes 621 studies with 888 treatment arms & 135,246 patients; 103 treatment arms with 3188 patients reported on resolution of diabetes. Resolution based on clinical and laboratory manifestations of diabetes resolved (off diabetes medications with normal fasting blood glucose [<100 mg/dL] or HbA1c [≤6%]),
Systematic review & meta-analysis reviewing 621 studies including 135,246 patients
Overall, T2DM 87% resolved or improved (78% resolved) for patients after bariatric surgery
Buchwald H, Estok R, Farbach K, et al. Weight and Type 2 Diabetes after Bariatric Surgery: Systematic Review and Meta-analysis. Am J Med. 2009;122(3): Figure adapted from source data. Data included includes 621 studies with 888 treatment arms & 135,246 patients; 103 treatment arms with 3188 patients reported on resolution of diabetes. Resolution based on clinical and laboratory manifestations of diabetes resolved (off diabetes medications with normal fasting blood glucose [<100 mg/dL] or HbA1c [≤6%]),

43. Klein (3 year matched cohort analysis)
46% fewer T2DM related claims for patients with bariatric surgery
The Klein study is a matched cohort study with claims data. 1,600 patients are included in 2 arms. The primary endpoint is to determine the economic impact and clinical benefits of bariatric surgery. The study is a 3 year study.
Reference
1. ) Klein S, Ghosh A, Cremieux PY, Eapen S, McGavock TJ. Economic impact of the clinical benefits of bariatric surgery in diabetes patients with BMI ≥35 kg/m2. Obesity. 2011;19:

44. Klein: 3-Year Matched Cohort Analysis (2011) 46% fewer T2DM-related claims for patients following bariatric surgery
The Klein study results showed that at 6 months, 28% of surgery patients reported a diabetes claim versus 74% of control patients. The trend in diabetes claims was sustained to 3 years. The result was 46% fewer T2DM related claims for patients with bariatric surgery.
56% fewer diabetes prescriptions were filled for bariatric surgery patients. 6 months post surgery only 34% of surgery patients had filled a prescription for diabetes medication in the previous three months compared to 90% of control patients. This difference is sustained to the end of the study period (3 years).
There was a significantly lower supply cost in diabetes medication for surgery patients. 3 months after bariatric surgery the average total cost of diabetes medications and supplies for surgery patients was $33 compared to $123 for control patients. Total monthly prescription drug costs for surgery patients were 72% lower at two years.
Reference
1. ) Klein S, Ghosh A, Cremieux PY, Eapen S, McGavock TJ. Economic impact of the clinical benefits of bariatric surgery in diabetes patients with BMI ≥35 kg/m2. Obesity. 2011;19:
56% fewer diabetes prescriptions were filled for bariatric surgery patients.
There was a significantly lower supply cost in diabetes medication for surgery patients.
Source: Klein S, Ghosh A, Cremieux PY, Eapen S, McGavock TJ. Economic impact of the clinical benefits of bariatric surgery in diabetes patients with BMI ≥35 kg/m2. Obesity. 2011;19:

45. Segal (AHRQ 1 – year cohort study)
76% decline in diabetes medication use at 12 months post-surgery
The Segal study was a matched cohort, claims data study with 8,400 patients with 2 arms. The primary endpoint of the study was to determine the impact of surgery to reduce utilization of CV meds.
Reference
1. ) Segal JB, Clark JM, Shore AD, et al. Prompt reduction in use of medications for comorbid conditions after bariatric surgery. Effective Healthcare Research Report No. 28. Rockville, MD: Agency for Healthcare Research and Quality;

46. Segal: AHRQ 1-Year Cohort Study (2010) 76% decline in diabetes medication use at 12 months post-surgery (p≤0.0001)
■ nonsurgical group
◊ surgical group
In this study there was a 55% decrease in the mean number of diabetes medications within three months. Patients without surgery had an increase in mean number of diabetes medications during the same period.
There was also a significant decline in cardiovascular medication use at 12 months post-surgery. Use of medication for hypertension & hyperlipidemia declined 51% and 59%, respectively, at 12 months post-surgery(p<0.0001). Patients without surgery had an increase in medications for hypertension and hyperlipidemia.
Reference
1. ) Segal JB, Clark JM, Shore AD, et al. Prompt reduction in use of medications for comorbid conditions after bariatric surgery. Effective Healthcare Research Report No. 28. Rockville, MD: Agency for Healthcare Research and Quality; (Fig 1, page 14)
Source: Segal JB, Clark JM, Shore AD, et al. Prompt reduction in use of medications for comorbid conditions after bariatric surgery. Effective Healthcare Research Report No. 28. Rockville, MD: Agency for Healthcare Research and Quality; (Fig 1, page 14)

47. Bolen (5 year matched cohort analysis)
Lower proportion - and likelihood - of having T2DM at 5 years post bariatric surgery
The Bolen study followed 22,693 patients who underwent bariatric surgery during The primary endpoint is to identify the % of obesity related co-morbidities between groups. The duration of the study is 5 years.
Reference
1. ) Bolen, Shari and others. Clinical Outcomes after Bariatric Surgery: A Five-Year Matched Cohort Analysis in Seven US States. Obesity Surgery (2012) 22:

48. Bolen: 5-Year Matched Cohort Analysis (2012) Lower proportion – and likelihood - having T2DM at 5yr following bariatric surgery
The study showed a lower proportion of patients with, and likelihood of having having, T2DM at 5 years with bariatric surgery.
Reference
1. ) Bolen, Shari and others. Clinical Outcomes after Bariatric Surgery: A Five-Year Matched Cohort Analysis in Seven US States. Obesity Surgery (2012) 22: , Figure adapted from source data. Non-concurrent, matched cohort study following 22,693 persons who underwent bariatric surgery using logistic regression between groups for up to 5 years.
Source: Bolen, Shari and others. Clinical Outcomes after Bariatric Surgery: A Five-Year Matched Cohort Analysis in Seven US States. Obesity Surgery (2012) 22: , Figure adapted from source data. Non-concurrent, matched cohort study following 22,693 persons who underwent bariatric surgery using logistic regression between groups for up to 5 years.

49. Swedish Obese Subjects (SOS)
Bariatric surgery appears to be markedly more efficient than usual care in the prevention of Type 2 diabetes in obese persons.
The Swedish Obesity Study was a 2 arm study with 5335 participants.
The result showed that Bariatric surgery appears to be markedly more efficient than the usual care in the prevention of Type 2 diabetes in obese persons. The study is a 20 year study with 15 results reported out in the New England Journal of Medicine.
Reference
1. ) Carlsson LMS, Peltonen M, Ahlin S et al, Bariatric Surgery and Prevention of Type 2 Diabetes in Swedish Obese Subjects. N Engl J Med 2012; 367:
Carlsson LMS, Peltonen M, Ahlin S et al, Bariatric Surgery and Prevention of Type 2 Diabetes in Swedish Obese Subjects. N Engl J Med 2012; 367:

50. Carlsson et al. Significantly lower incidence of Type 2 Diabetes in Bariatric / Metabolic Surgery group at 15 years
Here you can see that there was a significant reduction in the incidence of Type 2 Diabetes in the Bariatric surgery group at the 15 year mark.
Reference
1. ) Carlsson LMS, Peltonen M, Ahlin S et al, Bariatric Surgery and Prevention of Type 2 Diabetes in Swedish Obese Subjects. N Engl J Med 2012; 367:
Carlsson LMS, Peltonen M, Ahlin S et al, Bariatric Surgery and Prevention of Type 2 Diabetes in Swedish Obese Subjects. N Engl J Med 2012; 367:

51. Who to refer and how to refer to bariatric surgery
Now that you have a better understanding the treatment options, bariatric surgery in particular and recent clinical findings, I want to discuss who to refer to surgery and how to refer them.
Who to refer and how to refer to bariatric surgery

52. Who is a Surgical Candidate?
Meets National Institutes of Health Criteria: BMI ≥ 40 (or ≥ 35 with obesity-related co- morbidities)
Common insurance requirements:
18 years or older
Failed medically supervised weight loss attempts
Understands surgery and risks
Acceptable operative risks (patient and procedure)
Stable psychological condition: interview, psychotherapy, support groups as indicated
The NIH currently has guidelines out for who to refer to surgery and there are common insurance requirements.
The NIH guidelines identify someone that is morbidly obese as an appropriate referral.
Insurance guidelines will vary by region. Some of the common ones are:
They are 18 years or older
They have failed medically supervised weight loss attempts
The understand surgery and their risks
They have an acceptable operative risk level
They are psychologically stable, verified by an interview, psycholtherapy or support groups.
References
1.) National Institutes of Health. The practical guide: Identification, evaluation, and treatment of overweight and obesity in adults. NIH Publication Number ; 2000.

53. Having the Conversation with your Patients
Open the discussion for them – delicately and in a sensitive manner
Tools can help open the discussion (e.g. BMI)
Address your patient’s chief complaints first
Empathy and respect are important
Discuss the options for significant weight loss
If interested, suggest that they attend a seminar
An important early step is opening up the conversation with your patient. Here are some suggested steps.
First, always address your patient’s chief complaints first. If they are there for a cold, first address the cold – avoid placing blame for all health issues on their weight.
Open the weight discussion in a sensitive manner. Patients appreciate it when you bring up the conversation instead of waiting for them to bring it up. Utilize the measurement and illustrative tools that are available to help you such as the BMI Wheel / Chart; waist circumference measurement; posters or print outs showing the health issues caused by excess weight and treatment options.
Be empathy and respect. Show empathy for their struggles with weight control; let them know you want to partner with them to find the best treatment option. Be cautious of the words and phrasing you use. E.g. “You have morbid obesity” not “you are morbidly obese”
Discuss the options for weight loss. Use the treatment pyramid to guide which options you present to your patients. Present all options fairly and help patients understand how much weight they can expect to lose. Focus not just on weight loss, but overall health improvement.
If there are interested, suggest that they attend a seminar to learn more about their options.

54. What to provide for the surgical consultation
Healthcare Provider documentation on weight loss attempts
Letter from Healthcare Provider describing history of weight loss attempts
Insurance company requirement
Medical records
Pre-surgery H&P evaluation (if needed)
A Bariatric referral for consultation is similar to any other specialist referral. They will examine the patient to determine if surgery is the best option.
Here are some items to think about when making the refer. The bariatric surgeon will require this information.
A healthcare provider documentation on weight loss attempts
A letter from Healthcare Provider describing history of weight loss attempts
Medical records
A pre-surgery H&P evaluation (if needed)
The bariatric surgeon is your partner in treating the obese patient. They will examine the patient to determine if surgery is the best option.

55. What to Look for in a Bariatric Surgeon / Surgical Center
A Center of Excellence, the hallmark of which is the prospective database on patients including outcomes, safety data, and process improvement
A surgeon who works primarily as a bariatric surgeon and performs at least 50 cases per year
A surgeon/center that communicates at every stage in the patient process with your office and is available to answer questions
A program that features support groups for patient participation and a strong commitment to the psychological aspects of the program
Here are some important aspects to look for when selecting a surgeon or surgical center.
A Center of Excellence, the hallmark of which is the prospective database on patients which includes outcomes, safety data, and process improvement
A surgeon/center who works primarily as a bariatric surgeon and performs at least 50 cases per year
A surgeon/center that communicates at every stage in the patient process with your office and is available to answer questions.
A program that features support groups for patient participation and a strong commitment to the psychological aspects of the program

56. Insurance Coverage
Requirements for approval depend on insurance policy. Most require:
BMI >40 or >35 with significant co- morbidities
Documented history of medical weight loss attempts (3-6 months)
5 year weight history
Psychological evaluation
Nutrition counseling
It is important for each patient to know what their insurance covers. The items listed on this slide are typical requirements.
BMI >40 or >35 with significant co-morbidities
Documented history of medical weight loss attempts (3-6 months)
5 year weight history
Psychological evaluation
Nutrition counseling

57. Next Steps
In patient visits, determine which patients are appropriate for a bariatric surgery consult.
Identify bariatric surgeons in your area who meet your standards for referral.
Recommend bariatric surgery to selected obese patients
Rethink surgery as a therapeutic intervention, not just for severely obese patients*
The next steps for you are to –
In patient visits, determine which patients are appropriate for a bariatric surgery consult.
Identify bariatric surgeons in your area that you can refer to.
Recommend bariatric surgery to selected obese patients
Rethink surgery as a therapeutic intervention, not just for severely obese patients. 
* Schauer PR, Kashyap SR, Wolski K, et al. Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes. N Engl J Med. 2012; 366: and Cohen RV, Pinheiro JC, Schiavon CA et al. Effects of gastric bypass surgery in patients with type 2 diabetes and only mild obesity. Diabetes Care 2012; 35:

58. How to treat the post operative bariatric surgery patient
After one of your patients has had surgery, you might want to know how to treat the post operative bariatric patient. What is important for this patient in particular.
How to treat the post operative bariatric surgery patient

59. Post-Op expectations Recovery takes time and patience.
Weight loss amount and timing of weight loss vary
The diet will be strict
Patients may experience discomfort and pain as body heals
Length of time to return to normal activities varies
For band patients, they should expect ongoing band fill appointments
The typical post op expectations are that the patient understands that recovery takes time and patience. The weight loss amount and timing will vary by patient. The diet must be strict and lifestyle adaptations should be made. The patients will experience some discomfort and pain as the body heals. The surgeon and primary care practiconer will identify when the patient can return to normal activities. The timing will specific to each individual patient.
For banding patients, there will be an ongoing visit to check on the restrictiveness of the band and to make any adjustments that might be necessary.

60. Post-Op Management Post-operative pneumonia / atelectasis
Deep venous thrombosis / pulmonary embolism
Incisional infections
Nausea / vomiting / dehydration
Anastomotic & staple line leak
Thiamin deficiency
Diarrhea
Nutritional Screening / Supplements
Medication Adjustments
Bariatric patients have some important restrictions in medications and procedures they can have.
For any questions, check with the bariatric surgeon to confirm.
Some medications such as Coumadin are absorbed much more rapidly and may result in very high levels on the same dosage.
Medications such as anti-inflammatory medications should be used with extreme caution if at all.

61. Summary

62. A growing consensus favors bariatric surgery
“Bariatric surgery should be considered for adults with BMI ≥ 35 kg/m2 and type 2 diabetes, especially if the diabetes is difficult to control with lifestyle and pharmacologic therapy.”
– American Diabetes Association (2009)
“When indicated, surgical intervention leads to significant improvements in decreasing excess weight and co- morbidities that can be maintained over time.”
– American Heart Association (2011)
“Bariatric surgery is an appropriate treatment for people with type 2 diabetes and obesity not achieving recommended treatment targets with medical therapies”
– International Diabetes Federation (2011)
“The beneficial effect of surgery on reversal of existing DM and prevention of its development has been confirmed in a number of studies”
– American Association of Clinical Endocrinologists (2011)
There is currently a lot of talk about people being overweight, obese or morbidly obese in our society today and there are significant clinical studies underway to better understand all the benefits associated with bariatric procedures. With societies, there is growing consensus that favors bariatric surgery. Many of the major professional, medical associations have come out with statements positively supporting the procedure.
Sources: American Diabetes Association. Standards of medical care in diabetes – Diabetes Care 2009; 32(S1):S13-S61,
Poirier P, Cornier M-A, Mazzone T et al. Bariatric surgery and cardiovascular risk factors: A scientific statement from the American Heart Association. Circulation 2011; 123:00-00.
International Diabetes Federation. Bariatric surgical and procedural interventions in the treatment of obese patients with type 2 diabetes
Handelsman Y, Mechanick JI, Blone L et al. American Association of Clinical Endocrinologists medical guidelines for clinical practice for developing a diabetes mellitus comprehensive plan. Endocr Prac 2011; 17(Suppl 2).

63. A growing consensus favors bariatric surgery
“The Endocrine Society recommends that practitioners consider several factors in recommending surgery for their obese patients with type 2 diabetes, including patient’s BMI and age, the number of years of diabetes and the assessment of the (patient’s) ability to comply with the long-term lifestyle changes that are required to maximize success of surgery and minimize complications.”
“… remission of diabetes, even if temporary, will still lead to a reduction in the progression to secondary complications of diabetes (such as retinopathy, neuropathy and nephropathy), which would be an important outcome of … surgery.”
– The Endocrine Society (March 2012)
Many of the statements by society not only support bariatric surgery for weight loss, but for co-morbidity resolution such as T2DM.
For examples –
The Endocrine Society states that “remission of diabetes, even if temporary, will still lead to a reduction in the progression to secondary complications of diabetes”.
Reference
1. ) The Endocrine Society, Evaluating the Benefits of Treating Type 2 Diabetes with Bariatric Surgery, March 30, 2012.
Source: The Endocrine Society, Evaluating the Benefits of Treating Type 2 Diabetes with Bariatric Surgery, March 30, 2012.

64. Bariatric Surgery Conclusions
Most effective treatment for morbid obesity (SAGES)
Helps Type 2 diabetic patients achieve glycemic control more effectively than intensive medical therapy within 1 year (STAMPEDE & Mingrone)
Resolves or improves Type 2 diabetes and other obesity-related CV comorbidities for up to 5 years (STAMPEDE , Buchwald, Klein and Bolen)
Reduces medication use for Type 2 diabetes and other CV comorbidities for up to 3 years (STAMPEDE, AHRQ/Segal and Klein)
Results in morbidity & mortality rates that are similar to well-established general surgery procedures (DeMaria)
Reduces the risk of cardiovascular death (myocardial infarction or stroke) compared to customary intervention (Sjostrom)
Is an acceptable treatment option for obese patients with T2DM by professional medical societies including the ADA, AHA, IDF, AACE & the Endocrine Society.
In conclusion, Bariatric surgery –
is currently the most effective treatment for morbid obesity (SAGES)
It helps Type 2 diabetic patients achieve glycemic control more effectively than intensive medical therapy within 1 year (STAMPEDE & Mingrone)
It resolves or improves Type 2 diabetes and other obesity-related CV comorbidities for up to 5 years (STAMPEDE , Buchwald, Klein and Bolen)
It reduces medication use for Type 2 diabetes and other CV comorbidities for up to 3 years (STAMPEDE, AHRQ/Segal and Klein)
It results in morbidity & mortality rates that are similar to well-established general surgery procedures i.e. gallbladder surgery and hysterectomy (CMS)
It reduces the risk of cardiovascular death (myocardial infarction or stroke) compared to customary intervention (Sjostrom)
It achieved consensus as an acceptable treatment option for obese patients with T2DM by professional medical societies including the ADA, AHA, IDF, AACE & the Endocrine Society.

65. Summary
Obesity is a disease that is growing in prevalence and should be treated as a medical condition
Bariatric surgery is the most effective therapy available for morbid obesity*
Surgical weight loss impacts a number of co-morbidities associated with obesity
You can confidently make a bariatric surgery referral using clear and accepted clinical guidelines and assessment tools
The bariatric surgeon is a specialist available to you for the treatment of obese patients
Here’s the bottom line:
Obesity is a disease that is growing in prevalence and should be treated as a medical condition
Bariatric surgery is the most effective therapy available for morbid obesity
Surgical weight loss impacts a number of co-morbidities associated with obesity
You can confidently make a bariatric surgery referral using clear and accepted clinical guidelines and assessment tools (BMI)
The bariatric surgeon is a specialist available to you for the treatment of obese patients
References
1.) Poirer.P, Cornier M-A, Mazzone T. Bariatric surgery and cardiovascular risk factors: A scientific statement from the American Heart Association.Circulation 2011;123:
2.) SAGES Guidelines Committee. SAGES guideline for clinical application of laparoscopic bariatric surgery. Surg Endosc 2008 Oct;22(10):
* Poirer.P, Cornier M-A, Mazzone T. Bariatric surgery and cardiovascular risk factors: A scientific statement from the American Heart Association.Circulation 2011;123: and SAGES Guidelines Committee. SAGES guideline for clinical application of laparoscopic bariatric surgery. Surg Endosc 2008 Oct;22(10):

67. References for “There are significant co-morbidities associated with obesity”
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Mattar SG, Velcu LM, Rabinovitz M, et al. Surgically-induced weight loss significantly improves nonalcoholic fatty liver disease and the metabolic syndrome. Annals of Surgery 2005; 242(4):
National Institutes of Health. Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults. 1998; NIH Publication No
The Obesity Society. What is Obesity. Accessed May 19, 2010 from
Sugerman HJ, Sugerman EL, Wolfe L, et al. Risks and benefits of gastric bypass in morbidly obese patients with severe venous stasis disease. Annals of Surgery 234(1):41-46.
Yosipovitch G, DeVore A, Dawn A. Obesity and the skin: Skin physiology and skin manifestations of obesity. J Am AcadDermatol2007; 56:

68. References for “There are significant co-morbidity improvements associated with bariatric surgery”
OSA: Tice JA, Karliner L, Walsh J, et al. Gastric banding or bypass? A systematic review comparing the two most popular bariatric procedures. Am J Med Oct;121(10):
Asthma: Reddy RC, Baptist AP, Fan Z, et al. The effects of bariatric surgery on asthma severity. Obes Surg Feb;21(2):200-6.
Urinary stress incontinence: Kuruba R, Almahmeed T, Martinez F, et al. Bariatric surgery improves urinary incontinence in morbidly obese individuals. Surg Obes Relat Dis Nov- Dec;3(6):
Osteoarthritis & Depression: Schauer PR, Ikramuddin S, Gourash W, et al. Outcomes after laparoscopic Roux-en-Y gastric bypass for morbid obesity. Ann Surg Oct;232(4):
Migranes: Bond DS, Vithiananthan S, Nash JM, et al. Improvement of migraine headaches in severely obese patients after bariatric surgery. Neurology Mar 29;76(13):
Hypertension: Tice JA, Karliner L, Walsh J, et al. Gastric banding or bypass? A systematic review comparing the two most popular bariatric procedures. Am J Med Oct;121(10): and Ethicon analysis of data from US Clinical Trial PMA
NAFLD: Mattar SG, Velcu LM, Rabinovitz M, et al. Surgically-induced weight loss significantly improves nonalcoholic fatty liver disease and the metabolic syndrome. Ann Surg Oct;242(4):610-7.

69. References for “There are significant co-morbidity improvements associated with bariatric surgery”
Type 2 Diabetes: Schauer PR, Sangeeta KR, Wolski K et al. Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes. The New England Journal of Medicine 2012; 366(17):1567‐76.;
Adams TD, Davidson LE, Litwen SE et al.Health Benefits of Gastric Bypass Surgery After 6 Years. JAMA 2012; 308(11): 1122‐1131.;
Mingrone G, Panunzi S, De Gaetano A et al. Bariatric Surgery versus Conventional Medical Therapy for Type 2 Diabetes. The New England Journal of Medicine 2012; 366(17): 1577‐85.;
Dorman RB, Serrot FJ, Miller CJ et al. Case‐Matched Outcomes in Bariatric Surgery Treatment of Type 2 Diabetes in Morbidly Obese Patient. Ann Surg 2012; 255: 287‐293;

70. References for “There are significant co-morbidity improvements associated with bariatric surgery”
Tice JA, Karliner L, Walsh J et al. Gastric Banding or Bypass? A Systematic Review Comparing the Two Most Popular Bariatric Procedures. The American Journal of Medicine 2008: 121(10): 885‐93.;
Buchwald H, Avidor Y, Braunwald E et al. Bariatric Surgery: A Systematic Review and Meta‐ Analysis. JAMA 2004; 292:1724‐1737.
Wong SKH, Kong APS, So WY et al. Use of laparoscopic sleeve gastrectomy and adjustable gastric banding for suboptimally controlled diabetes in Hong Kong. Diabetes, Obesity and Metabolism 2011; 14(4): 372‐374;
Brethauer SA, Hammel JP Schauer PR et al. Review of sleeve gastrectomy as staging and primary bariatric procedure. Surgery for Obesity and Related Disease 2009; 5: 469‐475.