Lifestyle Intervention for Senior Diabetics

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Lifestyle Intervention Strategy to Treat Diabetes in Older Adults

Conditions
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Diabetes Mellitus, Aging, Overweight

Intervention / Treatment
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* Behavioral: Weight loss and Exercise
* Behavioral: Healthy lifestyle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects will be older (age 65-85 years) adults with type 2 diabetes. Diabetes will be determined by self-report with verification (medical records, current treatment, confirmation from health care provider, fasting glucose ≥126 mg/dL, symptoms of hyperglycemia with plasma glucose ≥200 mg/dL or 2-hour plasma glucose ≥200 mg/dL after a 75-g glucose load on at least two occasions, or HbA1C of ≥ 6.5%. All subjects will have a BMI of ≥ 27 kg/m2 and have stable weight (±2 kg) and on stable medications during the last 6 mos. Exclusion Criteria: Volunteers will be excluded if they fail to provide informed consent, have any major comorbid disease that is uncontrolled, or any condition that is likely to limit life span and/or affect the safety of the interventions, or interfere with the conduct of the trial. Examples include: 1) unstable cardiopulmonary disease (e.g. recent MI, unstable angina, stroke within past 3 months) or unstable disease (e.g. Class IV congestive heart failure: 2) severe orthopedic (e.g. awaiting joint replacement) and/or neuromuscular (e.g. multiple sclerosis, amyotrophic lateral sclerosis, active rheumatoid arthritis), 3) significant cognitive impairment, defined as a known diagnosis of dementia or positive screening test for dementia using the Mini-Mental State exam (i.e. MMSE score <24),43 4) cancer requiring treatment in the past 5 years, 5) documented history of pulmonary embolism in the past 6 months, 6) positive exercise stress test for cardiac ischemia, and 7) HbA1c >11%.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy Lifestyle Group<br>Group diabetes educations sessions that focus on diet, exercise, and social support. | Behavioral: Healthy lifestyle<br>* Diabetes support and education<br>|
| Experimental: Weight Loss plus Exercise Group<br>Behavioral therapy for weight loss and exercise training | Behavioral: Weight loss and Exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin A1c |  | baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insulin sensitivity |  | baseline and 12 months | 
| Change in insulin secretion |  | baseline and 12 months | 
| Change in fasting glucose |  | 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 |