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
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.
- 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.
- 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%.