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Completed

NCT Number: NCT02348801

Lifestyle Intervention for Senior Diabetics

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.

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Key information

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michael E DeBakey VA Medical Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

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.

Healthy lifestyle

Behavioral

Diabetes support and education

Primary outcomes

  1. Change in hemoglobin A1c

    Time frame: baseline and 12 months

Secondary outcomes

  1. Change in insulin sensitivity

    Time frame: baseline and 12 months

  2. Change in insulin secretion

    Time frame: baseline and 12 months

  3. Change in fasting glucose

    Time frame: baseline and 12 months

  4. Change in adipocytokines and hormones

    Time frame: baseline and 12 months

  5. Change in peak aerobic power

    Time frame: baseline and 12 months

  6. Change in cardiometabolic risk profile

    Time frame: baseline and 12 months

  7. Change in the modified physical performance test

    Time frame: baseline and 12 months

  8. Change in composite cognitive z-score

    Time frame: baseline and 12 months

  9. Change in quality of life

    Time frame: baseline and 12 months

  10. Change in health care utilization

    Time frame: baseline and 12 months

  11. Change in the modified mini-mental state exam

    Time frame: baseline and six months

  12. Change in muscle strength and quality

    Time frame: baseline and 12 months

  13. Change in gait speed

    Time frame: baseline and 12 months

  14. Change in stroop color naming

    Time frame: baseline and 12 months

  15. Change in word list fluency

    Time frame: baseline and 12 months

  16. Change in ray auditory verbal learning test

    Time frame: baseline and 12 months

  17. Change in Trail A./B

    Time frame: baseline and 12 months

  18. Change in Lean body mass

    Time frame: baseline and 12 months

  19. Change in fat mass and visceral fat

    Time frame: baseline and 12 months

  20. Change in bone mineral density

    Time frame: baseline and 12 months

  21. Change in bone metabolism

    Time frame: baseline and 12 months

  22. Change in bone quality

    Time frame: baseline and 12 months

  23. Change in composite cognitive score

    Time frame: baseline and 12 months

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • American Diabetes Association
  • Biomedical Research Institute of New Mexico
  • Michael E. DeBakey VA Medical Center

Registry information

Official study title

Lifestyle Intervention Strategy to Treat Diabetes in Older Adults

Acronym: LISD

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Jan 28, 2015
Registry last updated
Jan 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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