Lifestyle Intervention for Senior Diabetics (LISD)

Lifestyle Intervention Strategy to Treat Diabetes in Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Overweight; Aging
• Intervention / Treatment: Behavioral: Healthy lifestyle; Behavioral: Weight loss and Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Michael E DeBakey VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: American Diabetes Association; Michael E. DeBakey VA Medical Center; Biomedical Research Institute of New Mexico

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: January 21, 2015
• First Submitted That Met QC Criteria: January 27, 2015
• First Posted (Estimate): January 28, 2015

Study Record Updates

• Last Update Posted (Actual): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: H-34800