Lifestyle Intervention for Senior Diabetics

NCT02348801 | Completed DMC

• 1 other identifier: H-34800
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Aging; Overweight

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin A1c

  baseline and 12 months

Secondary Outcomes (23)

• 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

Study Arms (2)

Healthy Lifestyle Group

ACTIVE COMPARATOR

Group diabetes educations sessions that focus on diet, exercise, and social support.

Behavioral: Healthy lifestyle

Weight Loss plus Exercise Group

EXPERIMENTAL

Behavioral therapy for weight loss and exercise training

Behavioral: Weight loss and Exercise

Interventions

Weight loss and Exercise BEHAVIORAL

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.

Weight Loss plus Exercise Group

Healthy lifestyle BEHAVIORAL

Diabetes support and education

Healthy Lifestyle Group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%.

Sponsors & Collaborators

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

Study Sites (1)

Michael E DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 35880801 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Overweight

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dennis T Villareal, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: January 28, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 31, 2020
• Last Updated: January 14, 2021

Record last verified: 2021-01

Locations

US (1)