Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Diabetes Association | OTHER |
| Michael E. DeBakey VA Medical Center | FED |
| Biomedical Research Institute of New Mexico | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Older people with diabetes will be assigned to the 1-year lifestyle program or no lifestyle program while continuing usual treatment for diabetes. The lifestyle program will consist of teaching how to practice healthy diet and regular exercise at our facility and continued into the community and home. It is hoped that the results would provide convincing proof about the usefulness of lifestyle change in older patients with diabetes.
Background: Hypothesis: Lifestyle intervention will be highly successful in the population of older adults with diabetes, with resultant significant improvement in glycemic metabolic control mediated by improved insulin action/secretion, accompanied by significant improvements in physical function, cognitive function, and quality-of-life (QOL).
Rationale: Countering the prevailing notion that it is difficult to change lifelong habits, the PI has ample preliminary data showing successful lifestyle change in older adults. A similar lifestyle intervention augmented by motivational interviewing might also be successful in older adults with diabetes with eventual translation to the community- and home-settings.
Aims: In older adults with diabetes and comorbidities, the aims are to: determine the effect of lifestyle intervention on glycemic metabolic control, determine the mechanisms underlying lifestyle-induced changes in glucose homeostasis, and determine the effect of lifestyle intervention on age-relevant health outcomes: physical function, cognitive function, QOL.
Design: Older adults with diabetes and comorbidities will be randomized to center-based lifestyle intervention continued into the community and home vs. healthy-lifestyle control for 1 year.
Relevance to diabetes prevention and treatment: Data from a randomized-controlled trial will provide high-level evidence to convince practitioners to implement lifestyle intervention as the primary therapy for diabetes in older patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Lifestyle Group | Active Comparator | Group diabetes educations sessions that focus on diet, exercise, and social support. |
|
| Weight Loss plus Exercise Group | Experimental | Behavioral therapy for weight loss and exercise training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight loss and Exercise | Behavioral | Group behavior therapy sessions designed to acquire positive weight-control skills and attitudes, and practice weight-maintenance skills. A balanced diet will be prescribed to provide a deficit of 500-750 kcal/day from daily energy requirement. Exercise sessions of ~90 min duration 15 min warm-up of flexibility exercise, followed by ~30 min of aerobic exercise, and, after a brief rest period, ~30 min of resistance training, and finally ~15 min balance exercise) conducted three times weekly supervised at our exercise facility for first six months, and regular exercises continued at community-fitness centers and at home for the following six months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemoglobin A1c | baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in insulin sensitivity | baseline and 12 months | |
| Change in insulin secretion | baseline and 12 months | |
| Change in fasting glucose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dennis T Villareal, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael E DeBakey VA Medical Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35880801 | Derived | Celli A, Barnouin Y, Jiang B, Blevins D, Colleluori G, Mediwala S, Armamento-Villareal R, Qualls C, Villareal DT. Lifestyle Intervention Strategy to Treat Diabetes in Older Adults: A Randomized Controlled Trial. Diabetes Care. 2022 Sep 1;45(9):1943-1952. doi: 10.2337/dc22-0338. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Healthy lifestyle | Behavioral | Diabetes support and education |
|
| baseline and 12 months |
| Change in adipocytokines and hormones | baseline and 12 months |
| Change in peak aerobic power | baseline and 12 months |
| Change in cardiometabolic risk profile | baseline and 12 months |
| Change in the modified physical performance test | baseline and 12 months |
| Change in composite cognitive z-score | baseline and 12 months |
| Change in quality of life | baseline and 12 months |
| Change in health care utilization | baseline and 12 months |
| Change in the modified mini-mental state exam | baseline and six months |
| Change in muscle strength and quality | baseline and 12 months |
| Change in gait speed | baseline and 12 months |
| Change in stroop color naming | baseline and 12 months |
| Change in word list fluency | baseline and 12 months |
| Change in ray auditory verbal learning test | baseline and 12 months |
| Change in Trail A./B | baseline and 12 months |
| Change in Lean body mass | baseline and 12 months |
| Change in fat mass and visceral fat | baseline and 12 months |
| Change in bone mineral density | baseline and 12 months |
| Change in bone metabolism | baseline and 12 months |
| Change in bone quality | baseline and 12 months |
| Change in composite cognitive score | baseline and 12 months |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |