1. Intensive Lifestyle Intervention in Older Adults with Diabetes Improves Glycemic Control, Body Composition, Physical Function, and Bone Quality Alessandra Celli1,2,3, Dean Blevins1,2, Yoann Barnouin1,2, Georgia Colleluori1,2,3, Reina Armamento-Villareal1,2, Dennis Villareal1,2   1Baylor College of Medicine; 2 Center for Translational Research on Inflammatory Diseases (CTRID), Michael E. DeBakey VA Medical Center, Houston, TX; 3Univeristy Campus Bio-Medico di Roma
Alessandra Celli
April 1, 2016

2. DISCLOSURE
Nothing to disclose

3. DIABETES EPIDEMIC
From 1980 through 2014, the number of U.S. adults aged 18 years or older with diagnosed diabetes has almost quadrupled (from 5.5 million to 21.9 million).
Diabetes Public Health Resource

4. DIABETES IN OLDER ADULTS
Diagnosed and undiagnosed diabetes aged 20 years or older, United States, 2012

5. DIABETES IN OLDER ADULTS
Increasing prevalence due to:
- Obesity epidemic
- Aging of the population
CONFLUENCE of 2 EPIDEMICS
Roubenoff R., SARCOPENIC OBESITY: THE CONFLUENCE OF TWO EPIDEMIC
Obes Res 2004; 12:
Combined effect on:
Reduced pancreatic islet function
Increased insulin resistance

6. DIABETES TREATMENT
PHYSICAL ACTIVITY
DIET
DIABETES
MEDICATIONS

7. DIABETES IN OLDER ADULTS: TREATMENT
Older adults have the highest prevalence of diabetes
(and associated comorbidities)
Lifestyle intervention is the MAINSTAY of treatment for diabetes
Older diabetic patients are typically excluded from studies on the treatment for diabetes
Lifestyle intervention treatment remains EMPIRIC for elderly people
It is only based on expert opinion
There is not a HIGH LEVEL of EVIDENCE

8. DIABETES IN OLDER ADULTS:TREATMENT
WEIGHT LOSS THERAPY IN OLDER ADULTS:
Could it be harmful?
Worsen frailty?
Exacerbate sarcopenia?
Bone loss / increased fracture risk?
Difficulty in changing lifelong habits (diet and activity)?
Distress, anxiety
No compliance

9. LIFESTYLE INTERVENTION for SENIOR DIABETICS (LISD): NCT02348801
Overall Purpose
To perform a Randomized Controlled Trial (RCT) to determine the effect of weight loss therapy in older (age: ≥ 65 yrs.) adults with diabetes

10. METHOD / DESIGN
Specific Aims: RCT in older adults with diabetes of the effect
of lifestyle intervention (diet and exercise) on:
Glucose metabolic control
Physical Function
Body Composition
BMD and Bone Quality
Study Duration: months
Sample size: subjects
INTERVENTION: Randomization to groups:
1. Intensive Lifestyle Intervention group
2. Healthy Lifestyle (control) group

11. METHOD / DESIGN Assessments Glucose Metabolic Control Change in HbA1c
Physical Function
Change in Physical Performance Tests (PPT) score
Change in Peak Aerobic Capacity (VO2peak )
Body Composition
Change in Fat Mass and Fat-Free Mass using DXA (Horizon A DXA system)
BMD and Bone Quality
Change in BMD using DXA (Horizon A DXA system)
Change in Trabecular Bone Score (TBS) using TBS iNsight® software

12. TRABECULAR BONE SCORE (TBS)
A textural index that evaluates pixel gray‐level variations in the lumbar spine DXA image
Index of trabecular microarchitecture
Silva BC et al. JBMR. 2014

13. METHOD / DESIGN ELIGIBILITY Inclusion criteria Exclusion criteria
Age 65 to 85 years, BMI of ≥ 27 kg/m2
Previous diagnosis of type 2 diabetes
Stable weight (±2 kg) and stable medications
Exclusion criteria
Condition that can limit or affect the safety of the interventions
Unstable cardiopulmonary disease
Severe orthopedic and/or neuro-muscular condition
Cognitive impairment
Cancer requiring treatment
History of pulmonary embolism
Positive exercise stress test for cardiac ischemia
HbA1c >11%.

14. METHOD / DESIGN INTERVENTION GROUPS LIFESTYLE INTERVENTION GROUP
PHASE - first 6 months
Diet class for weight loss - once per week
Supervised exercise training -3 times a week
PHASE - second 6 months
Diet class for maintaining weight loss - twice per month
Exercises at community based fitness centers & at home
HEALTHY LIFESTYLE GROUP
PHASE - 12 months
Monthly meeting:
Diabetes management
Nutritional / Diet education
Body weight checking

15. Lifestyle Intervention group N= 10 Healthy Lifestyle group N= 7
PRELIMINARY RESULTS
Baseline Characteristics
Mean ± SD
Characteristic
Lifestyle Intervention group N= 10
Healthy Lifestyle group N= 7
p value
Age (year)
70 ± 5
70 ± 2
0.57
BMI (kg/m2)
37.2 ± 6.2
32.6±5.1
0.13
HbA1c (%)
7.5 ±1.2
7.1±1.2
0.51
PPT score
26.1± 5.3
23.5± 6.1
0.38
VO2peak (mL/kg/min)
16.8± 3.0
16.4 ± 5.8
0.88
Body weight (kg)
109.5± 24.7
97.7± 23.9
0.34
Fat Free Mass (kg)
63.7 ± 12.2
60.1 ± 11.6
0.55
Fat Mass (kg)
41.3 ± 6.6
37.6 ± 7.0
0.29
Lumbar Spine BMD (g/cm2)
1.228 ± 0.156
1.188 ± 0.157
0.61
Lumbar Spine TBS
1.190 ± 0.186
1.195 ± 0.107
0.96
Hip Total BMD (g/cm2)
1.117 ± 0.148
1.067 ± 0.090
0.16
Use of diabetes medications (no)
Oral medications
Insulin 9 5 3
0.32
0.77

16. Lifestyle Intervention group Healthy Lifestyle group
PRELIMINARY RESULTS
Effect of Intervention
Outcome Variables
Mean ± SD
Lifestyle Intervention group
N = 7
Healthy Lifestyle group
N = 6
p value
HbA1c (%)
-0.7± 0.2
+0.2±0.4%
< 0.001
Body weight (kg)
-8.1± 3.2
-1.9±7.7
0.08
Fat Mass (kg)
-4.6 ± 3.2
-2.1 ± 6.6
0.02
Visceral Fat Mass (kg)
-0.2 ± 0.2
0.0 ± 0.1
0.04
Fat Free Mass (kg)
0.3 ± 3.4
0.9 ± 5.1
0.80
PPT Score
3.3 ± 1.6
1.2 ± 6.5
0.01
VO2peak (mL/kg/min)
2.7 ± 1.1
0.4 ± 1.5
0.007
Lumbar Spine BMD (g/cm2)
0.146 ± 0.244
0.138 ± 0.360
0.96
Lumbar Spine TBS
0.09 ± 0.0
-0.02 ± 0.0
0.03
Hip Total BMD (g/cm2)
0.010 ± 0.017
0.008 ± 0.007
0.85

21. OUR RESULTS PROVIDE PRELIMINARY EVIDENCE THAT:
Intensive lifestyle intervention in older adults with T2D:
Feasible
Confers beneficial effects on:
glucose control
body composition
physical function
Bone quality may improve independent of changes in BMD in response to lifestyle intervention.
Long-term studies involving a larger sample are needed to follow up on these encouraging results and examine underlying mechanisms.

22. Thanks PRINCIPAL INVESTIGATOR: Dennis Villareal, MD
CO-INVESTIGATORS: Dean Blevins, MD
Yoann Barnouin, PhD
Georgia Colleluori
Reina Villareal, MD
Sanjay Mediwala, MD
Eleonora Balibalita
John Wade
American Diabetes Association, 1-14-LLY-38