1. “How Can Providers Address the Lack of R01 Studies. ” Robert H
“How Can Providers Address the Lack of R01 Studies?” Robert H. Eckel, M.D. Professor of Medicine Professor of Physiology and Biophysics University of Colorado Denver

2. First, what do we know about NIH support for obesity science?

3. NIH Research Obesity Task Force
Established by NIH Director Dr. Elias Zerhouni in April 2003.
A new effort to accelerate progress in obesity research across the NIH.
Co-Chaired
Dr. Griffin P. Rogers, Director NIDDK
Dr. Elizabeth G. Nabel, Director NHLBI

4. Strategic Plan for NIH Obesity Research
Prevention and treatment of obesity through lifestyle intervention.
Prevention and treatment of obesity pharmacologic, surgical, or other medical approaches.
Breaking the link between obesity and its associated health conditions.
Cross-cutting topics including health disparities, technology, fostering interdisciplinary teams, investigator training, translational research and educational/outreach efforts.

5. NIH Components Represented on the Obesity Task Force
National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK)
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Center for Complementary and Alternative Medicine (NCCAM)
National Center on Minority Health and Health Disparities (NCMHD)
National Center for Research Resources (NCRR)
NIH Division of Nutrition Research Coordination (DNRC)
NIH Fogarty International Center (FIC)
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Dietary Supplements (ODS)
Office of Disease Prevention (ODP)
Office of Research on Women's Health (ORWH)
Center for Scientific Review (CSR)

6. Presently, the NIH cannot accurately provide information on the # of R01s that address obesity science. This will change once the categorization has been modified – see

7. NIH Obesity-Related Funding
2004 Actual
2005 Actual
2006 Actual
2007 Actual
2008 Est’d
2009 Est’d
$423M
$519M
$594M
$661M
$660M
$659M

8. NIH Obesity Research Funding Opportunities
Obesity Research Solicitations Currently Accepting Applications
RFAs
RFA-DK : Neuroimaging in Obesity Research (R01) RFA-HL : Translating Basic Behavioral and Social Science Discoveries into Interventions to Reduce Obesity: Centers for Behavioral Intervention Development (U01) RFA-HD : Innovative Computational and Statistical Methodologies for the Design and Analysis of Multilevel Studies on Childhood Obesity (R01) RFA-DK : Limited Competition: Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) (U01)
PAs
n = 46
Ongoing Clinical Trials (Federal and Private) - ClinicalTrials.gov
n = 1328

9. A major question is – do we know that weight loss prolongs life?

10. And the only data come from one study of bariatric surgery!

11. Effects of Bariatric Surgery on Weight in Swedish Obese Subjects
Sjostrom LA et al NEJM 357:471, 2007

12. Effects of Bariatric Surgery on Mortality in Swedish Obese Subjects
Sjostrom LA et al NEJM 357:471, 2007

13. Will Look AHEAD Answer All the Questions?
Primary Objective: Assess long-term (11.5 yr) effects of an intensive weight loss program over 4 years in overweight and obese subjects with type 2 diabetes.
n ~ 5000 men and women
age: yr
BMI > 25 kg/m2
Primary outcome – time to a major CVD event
Secondary outcomes – many including all cause mortality
Controlled Clin Trials 24:610, 2003

14. Mean Change from Baseline
Look AHEAD Trial: Improvement in Metabolic Syndrome Components at 1 Year
Mean Change from Baseline
P value
Intensive Lifestyle
Diabetes Support/
Education
Weight Loss (%)
8.6%
0.7%
<0.001
Waist Circumference (cm)
–6.2
–0.5
TG (mg/dL)
–30.3
–14.6
HDL-C (mg/dL)
3.4
1.4
Systolic BP (mm Hg)
–6.8
–2.8
Fasting Plasma Glucose (mg/dL)
–21.5
–7.2
Metabolic Syndrome (%)
–14.7
–7.1
Look AHEAD Research Group. Diabetes Care 30:1374, 2007

15. Obesity Research Support Related Questions
What kind of priority should NIH-supported obesity research funding receive?
How much money is needed?
If sufficient funding is provided, how much impact will result?
What is the role of industry?