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Lifestyle Intervention for Senior Diabetics (LISD)

Primary Purpose

Diabetes Mellitus, Aging, Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight loss and Exercise
Healthy lifestyle
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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%.

Sites / Locations

  • Michael E DeBakey VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Healthy Lifestyle Group

Weight Loss plus Exercise Group

Arm Description

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

Behavioral therapy for weight loss and exercise training

Outcomes

Primary Outcome Measures

Change in hemoglobin A1c

Secondary Outcome Measures

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

Full Information

First Posted
January 21, 2015
Last Updated
January 13, 2021
Sponsor
Baylor College of Medicine
Collaborators
American Diabetes Association, Michael E. DeBakey VA Medical Center, Biomedical Research Institute of New Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT02348801
Brief Title
Lifestyle Intervention for Senior Diabetics
Acronym
LISD
Official Title
Lifestyle Intervention Strategy to Treat Diabetes in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
American Diabetes Association, Michael E. DeBakey VA Medical Center, Biomedical Research Institute of New Mexico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Aging, Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Lifestyle Group
Arm Type
Active Comparator
Arm Description
Group diabetes educations sessions that focus on diet, exercise, and social support.
Arm Title
Weight Loss plus Exercise Group
Arm Type
Experimental
Arm Description
Behavioral therapy for weight loss and exercise training
Intervention Type
Behavioral
Intervention Name(s)
Weight loss and Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Healthy lifestyle
Intervention Description
Diabetes support and education
Primary Outcome Measure Information:
Title
Change in hemoglobin A1c
Time Frame
baseline and 12 months
Secondary Outcome Measure Information:
Title
Change in insulin sensitivity
Time Frame
baseline and 12 months
Title
Change in insulin secretion
Time Frame
baseline and 12 months
Title
Change in fasting glucose
Time Frame
baseline and 12 months
Title
Change in adipocytokines and hormones
Time Frame
baseline and 12 months
Title
Change in peak aerobic power
Time Frame
baseline and 12 months
Title
Change in cardiometabolic risk profile
Time Frame
baseline and 12 months
Title
Change in the modified physical performance test
Time Frame
baseline and 12 months
Title
Change in composite cognitive z-score
Time Frame
baseline and 12 months
Title
Change in quality of life
Time Frame
baseline and 12 months
Title
Change in health care utilization
Time Frame
baseline and 12 months
Title
Change in the modified mini-mental state exam
Time Frame
baseline and six months
Title
Change in muscle strength and quality
Time Frame
baseline and 12 months
Title
Change in gait speed
Time Frame
baseline and 12 months
Title
Change in stroop color naming
Time Frame
baseline and 12 months
Title
Change in word list fluency
Time Frame
baseline and 12 months
Title
Change in ray auditory verbal learning test
Time Frame
baseline and 12 months
Title
Change in Trail A./B
Time Frame
baseline and 12 months
Title
Change in Lean body mass
Time Frame
baseline and 12 months
Title
Change in fat mass and visceral fat
Time Frame
baseline and 12 months
Title
Change in bone mineral density
Time Frame
baseline and 12 months
Title
Change in bone metabolism
Time Frame
baseline and 12 months
Title
Change in bone quality
Time Frame
baseline and 12 months
Title
Change in composite cognitive score
Time Frame
baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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%.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis T Villareal, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E DeBakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35880801
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.
Results Reference
derived

Learn more about this trial

Lifestyle Intervention for Senior Diabetics

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