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.

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%.