Lifestyle Intervention for Senior Diabetics

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.

• 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.
• Healthy lifestyle (Behavioral): Diabetes support and education

Primary outcomes

• Change in hemoglobin A1c [baseline and 12 months]

Secondary outcomes

• 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]

Sex: All, ages: 65 Years to 85 Years

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%.

• Results publication: 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. PMID 35880801

• Dennis T Villareal, MD, Principal investigator, Baylor College of Medicine