Clinical trial NCT02348801: Lifestyle Intervention for Senior Diabetics
Official title: Lifestyle Intervention Strategy to Treat Diabetes in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Aging
Overweight
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
name: Michael E. DeBakey VA Medical Center
name: Biomedical Research Institute of New Mexico
First posted: 2015-01-28
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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%.

Primary outcomes:
measure: Change in hemoglobin A1c
timeFrame: baseline and 12 months
Secondary outcomes:
measure: Change in insulin sensitivity
timeFrame: baseline and 12 months
measure: Change in insulin secretion
timeFrame: baseline and 12 months
measure: Change in fasting glucose
timeFrame: baseline and 12 months
measure: Change in adipocytokines and hormones
timeFrame: baseline and 12 months
measure: Change in peak aerobic power
timeFrame: baseline and 12 months
measure: Change in cardiometabolic risk profile
timeFrame: baseline and 12 months
measure: Change in the modified physical performance test
timeFrame: baseline and 12 months
measure: Change in composite cognitive z-score
timeFrame: baseline and 12 months
measure: Change in quality of life
timeFrame: baseline and 12 months
measure: Change in health care utilization
timeFrame: baseline and 12 months
measure: Change in the modified mini-mental state exam
timeFrame: baseline and six months
measure: Change in muscle strength and quality
timeFrame: baseline and 12 months
measure: Change in gait speed
timeFrame: baseline and 12 months
measure: Change in stroop color naming
timeFrame: baseline and 12 months
measure: Change in word list fluency
timeFrame: baseline and 12 months
measure: Change in ray auditory verbal learning test
timeFrame: baseline and 12 months
measure: Change in Trail A./B
timeFrame: baseline and 12 months
measure: Change in Lean body mass
timeFrame: baseline and 12 months
measure: Change in fat mass and visceral fat
timeFrame: baseline and 12 months
measure: Change in bone mineral density
timeFrame: baseline and 12 months
measure: Change in bone metabolism
timeFrame: baseline and 12 months
measure: Change in bone quality
timeFrame: baseline and 12 months
measure: Change in composite cognitive score
timeFrame: baseline and 12 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E DeBakey VA Medical Center
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Dennis T Villareal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.