Diabetes MellitusLISDNCT02348801
Lifestyle Intervention for Senior Diabetics
A study testing Weight loss and Exercise and Healthy lifestyle in people with Diabetes Mellitus and Aging, run by Baylor College of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Diabetes Mellitus, Aging, Overweight
- What is being tested?
- Weight loss and Exercise and Healthy lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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%.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E DeBakey VA Medical Center
Houston, Texas, 77030
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Aging, Overweight
- Being tested
- Weight loss and Exercise, Healthy lifestyle
- Medical subject headings
- Diabetes Mellitus, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss and ExerciseBehavioural
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 lifestyleBehavioural
Diabetes support and education
| Study group | Role | What they receive |
|---|---|---|
| Healthy Lifestyle Group | Active comparator | Group diabetes educations sessions that focus on diet, exercise, and social support. Receives: Behavioral: Healthy lifestyle |
| Weight Loss plus Exercise Group | Experimental | Behavioral therapy for weight loss and exercise training Receives: Behavioral: Weight loss and Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin A1c
Measured: baseline and 12 months
Secondary outcomes (23)
Change in insulin sensitivity
Measured: baseline and 12 months
Change in insulin secretion
Measured: baseline and 12 months
Change in fasting glucose
Measured: baseline and 12 months
Change in adipocytokines and hormones
Measured: baseline and 12 months
Change in peak aerobic power
Measured: baseline and 12 months
Change in cardiometabolic risk profile
Measured: baseline and 12 months
Change in the modified physical performance test
Measured: baseline and 12 months
Change in composite cognitive z-score
Measured: baseline and 12 months
Change in quality of life
Measured: baseline and 12 months
Change in health care utilization
Measured: baseline and 12 months
Change in the modified mini-mental state exam
Measured: baseline and six months
Change in muscle strength and quality
Measured: baseline and 12 months
Change in gait speed
Measured: baseline and 12 months
Change in stroop color naming
Measured: baseline and 12 months
Change in word list fluency
Measured: baseline and 12 months
Change in ray auditory verbal learning test
Measured: baseline and 12 months
Change in Trail A./B
Measured: baseline and 12 months
Change in Lean body mass
Measured: baseline and 12 months
Change in fat mass and visceral fat
Measured: baseline and 12 months
Change in bone mineral density
Measured: baseline and 12 months
Change in bone metabolism
Measured: baseline and 12 months
Change in bone quality
Measured: baseline and 12 months
Change in composite cognitive score
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2018
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association, Michael E. DeBakey VA Medical Center, Biomedical Research Institute of New Mexico
- Responsible party
- Principal investigator, Dennis T. Villareal, Baylor College of Medicine
- Investigators
- Dennis T Villareal, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348801
- Sponsor's protocol ID
- H-34800
- Acronym
- LISD
- Status last verified
- Jan 2021
- First submitted
- 21 Jan 2015
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 35880801
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Intervention Strategy to Treat Diabetes in Older Adults
- ClinicalTrials.gov ID
- NCT02348801
- Acronym / sponsor ID
- LISD / H-34800
- Conditions
- Diabetes Mellitus, Aging, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- American Diabetes Association, Michael E. DeBakey VA Medical Center, Biomedical Research Institute of New Mexico
- Study start
- Jan 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Lifestyle Group | Active comparator | Behavioral: Healthy lifestyleGroup diabetes educations sessions that focus on diet, exercise, and social support. |
| Weight Loss plus Exercise Group | Experimental | Behavioral: Weight loss and ExerciseBehavioral therapy for weight loss and exercise training |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight loss and ExerciseGroup 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. | Behavioural | Weight Loss plus Exercise Group |
| Healthy lifestyleDiabetes support and education | Behavioural | Healthy Lifestyle Group |
Primary outcome
Change in hemoglobin A1c
Time frame: baseline and 12 months
23 secondary outcomes
Change in insulin sensitivity
Time frame: baseline and 12 months
Change in insulin secretion
Time frame: baseline and 12 months
Change in fasting glucose
Time frame: baseline and 12 months
Change in adipocytokines and hormones
Time frame: baseline and 12 months
Change in peak aerobic power
Time frame: baseline and 12 months
Change in cardiometabolic risk profile
Time frame: baseline and 12 months
Change in the modified physical performance test
Time frame: baseline and 12 months
Change in composite cognitive z-score
Time frame: baseline and 12 months
Change in quality of life
Time frame: baseline and 12 months
Change in health care utilization
Time frame: baseline and 12 months
Change in the modified mini-mental state exam
Time frame: baseline and six months
Change in muscle strength and quality
Time frame: baseline and 12 months
Change in gait speed
Time frame: baseline and 12 months
Change in stroop color naming
Time frame: baseline and 12 months
Change in word list fluency
Time frame: baseline and 12 months
Change in ray auditory verbal learning test
Time frame: baseline and 12 months
Change in Trail A./B
Time frame: baseline and 12 months
Change in Lean body mass
Time frame: baseline and 12 months
Change in fat mass and visceral fat
Time frame: baseline and 12 months
Change in bone mineral density
Time frame: baseline and 12 months
Change in bone metabolism
Time frame: baseline and 12 months
Change in bone quality
Time frame: baseline and 12 months
Change in composite cognitive score
Time frame: baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Derived from this study: PubMed 35880801Celli 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.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis T Villareal, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss and Exercise and Healthy lifestyle in people with Diabetes Mellitus and Aging, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemoglobin A1c (time frame: baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02348801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.