Lifestyle Intervention for Senior Diabetics

Diabetes Mellitus Clinical Trial

— LISD  

Official title:

Lifestyle Intervention Strategy to Treat Diabetes in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02348801
• Other study ID #: H-34800
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Aging
• Diabetes Mellitus
• Overweight

Intervention

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.
• Healthy lifestyle
Diabetes support and education

Locations

Country	Name	City	State
United States	Michael E DeBakey VA Medical Center	Houston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Baylor College of Medicine	American Diabetes Association, Biomedical Research Institute of New Mexico, Michael Debakey Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemoglobin A1c		baseline and 12 months
Secondary	Change in insulin sensitivity		baseline and 12 months
Secondary	Change in insulin secretion		baseline and 12 months
Secondary	Change in fasting glucose		baseline and 12 months
Secondary	Change in adipocytokines and hormones		baseline and 12 months
Secondary	Change in peak aerobic power		baseline and 12 months
Secondary	Change in cardiometabolic risk profile		baseline and 12 months
Secondary	Change in the modified physical performance test		baseline and 12 months
Secondary	Change in composite cognitive z-score		baseline and 12 months
Secondary	Change in quality of life		baseline and 12 months
Secondary	Change in health care utilization		baseline and 12 months
Secondary	Change in the modified mini-mental state exam		baseline and six months
Secondary	Change in muscle strength and quality		baseline and 12 months
Secondary	Change in gait speed		baseline and 12 months
Secondary	Change in stroop color naming		baseline and 12 months
Secondary	Change in word list fluency		baseline and 12 months
Secondary	Change in ray auditory verbal learning test		baseline and 12 months
Secondary	Change in Trail A./B		baseline and 12 months
Secondary	Change in Lean body mass		baseline and 12 months
Secondary	Change in fat mass and visceral fat		baseline and 12 months
Secondary	Change in bone mineral density		baseline and 12 months
Secondary	Change in bone metabolism		baseline and 12 months
Secondary	Change in bone quality		baseline and 12 months
Secondary	Change in composite cognitive score		baseline and 12 months