AgingNCT00554112
Regulation of B-Cell Function & Glucose Tolerance in Older People
A study testing Exercise in people with Aging and Glucose Intolerance, run by US Department of Veterans Affairs.
Trial summary
This VA CDA-2 proposal will test in detail if lifestyle intervention with aerobic exercise training improves the body's production of insulin in older people at risk to develop diabetes. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Aging, Glucose Intolerance
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Aug 2011
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sedentary (defined as activity level of no more than occasional short bouts of walking per week), community-dwelling older veterans and non-veterans age 60-80 years. Special recruitment efforts will focus on enrollment of veterans.
- Fasting glucose <126 mg/dl and 2-hr glucose 140-199 mg/dl (IGT) during OGTT.
- BMI 26-36 kg/m2.
Who cannot join
- Current use of oral anti-diabetic agents, insulin, systemic steroids, beta-blockers, thiazides.
- Abnormal screening exercise stress test: exercise-induced sustained arrhythmia, symptomatic myocardial ischemia, ischemic EKG changes (>2mm ST-T depression in non Q-wave lead) during screening maximum treadmill test.
- Clinically significant cardiac disease defined as congestive heart failure (CHF) requiring pharmacologic therapy or New York Heart Association (NYHA) Class 3 or 4 cardiac status, atrial fibrillation, symptomatic obstructive valvular disease, high-grade AV block, unstable angina, or myocardial infarction within the last 12 months.
- Participation in a physical therapy, exercise or diet program.
- Significant orthopedic or musculoskeletal conditions.
- Clinically significant renal disease and/or serum creatinine > 2.0 mg/dl.
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- Hemoglobin <10 g/l.
- Clinically significant liver disease and/or ALT > 2.5 fold the upper limit of normal.
- Clinically significant medical history or physical findings (e.g. chronic lung disease, cancer) detected at the screening assessment.
- Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation.
About this study
This VA CDA-2 proposal will test in detail if lifestyle intervention with aerobic exercise training improves the body's production of insulin in older people at risk to develop diabetes.
Read the detailed description
There is a high prevalence of type 2 diabetes and impaired glucose tolerance (IGT) in the older population. Aging is associated with insulin resistance and impaired insulin secretion, with greater defects in older people with IGT. Beta-cell dysfunction is critical in the progression from normal glucose to tolerance to IGT and to diabetes.
In the Diabetes Prevention Program (DPP), lifestyle intervention with diet and exercise training significantly lowered the rate of progression from IGT to diabetes, and was particularly effective in older people. The mechanisms of lifestyle changes to prevent diabetes and the effects on beta-cell function remain unclear. Exercise is well-known to increase insulin sensitivity, although exercise effects on beta-cell function have not been specifically assessed. In a pilot study supported by local VA funds, one week of aerobic exercise training improved insulin sensitivity as expected, but also improved beta-cell function in sedentary older people with IGT, with no change in body weight/composition, fasting glucose or lipid/inflammatory parameters.
Based on my current VA RCDA project and the pilot study results, this VA CDA-2 proposal will test in detail the novel overall hypothesis that lifestyle intervention with aerobic exercise training leads to improved beta-cell function in human age-related glucose intolerance. The potential mechanisms of the age-associated decline in beta-cell function and whereby exercise training may improve beta-cell function will also be explored. Beta-cell function will be examined in relation to expected improvements in insulin sensitivity, and the effects of exercise will be isolated with weight maintenance and nutritional balance. The time course of exercise effects over three months, the acute and chronic effects of exercise training on beta-cell function, the effects of high vs. low intensity exercise training, and different important components of beta-cell function will be examined. The interaction between exercise training effects on beta-cell function in older people with IGT and potential mediators including free fatty acids (FFA)/FFA composition, intraabdominal fat, adipocytokines, and incretin hormones will be examined.
In light of the striking effectiveness of the DPP lifestyle intervention to prevent diabetes in older people with IGT, the decline in beta-cell function with even normal human aging, and the importance of beta-cell dysfunction in the progression to diabetes, it is of great interest to further define the potential, novel metabolic effects of exercise training on beta-cell function, particularly in the aging population. This project may provide initial steps to further determine the mechanisms whereby lifestyle changes prevent diabetes. This would provide critical information needed to translate research findings into clinical practice in order to prevent diabetes in the aging veteran population.
- Conditions
- Aging, Glucose Intolerance
- Being tested
- Exercise
- Keywords
- Exercise Training, Glucose Intolerance, Human Aging, Insulin Secretion
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Exercise
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Exercise Receives: Behavioral: Exercise |
| 2 | Active comparator | Exercise Receives: Behavioral: Exercise |
| 3 | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise effect on beta-cell function at 3 months
Measured: 3 months
Secondary outcomes (1)
Exercise effects glucose tolerance, intraabdominal fat, lipids, glycerol, GLP-1, adiponectin, and leptin.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: PI left the VA, per Central Office
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- American Diabetes Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554112
- Sponsor's protocol ID
- CDA-2-017-07F
- Status last verified
- Aug 2011
- First submitted
- 5 Nov 2007
- Last updated
- 11 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of B-Cell Function & Glucose Tolerance in Older People
- ClinicalTrials.gov ID
- NCT00554112
- Acronym / sponsor ID
- CDA-2-017-07F
- Conditions
- Aging, Glucose Intolerance
- Keywords
- Exercise Training, Glucose Intolerance, Human Aging, Insulin Secretion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left the VA, per Central Office
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- American Diabetes Association
- Study start
- Nov 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 6 Nov 2007 (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.
This VA CDA-2 proposal will test in detail if lifestyle intervention with aerobic exercise training improves the body's production of insulin in older people at risk to develop diabetes.
Detailed description
There is a high prevalence of type 2 diabetes and impaired glucose tolerance (IGT) in the older population. Aging is associated with insulin resistance and impaired insulin secretion, with greater defects in older people with IGT. Beta-cell dysfunction is critical in the progression from normal glucose to tolerance to IGT and to diabetes.
In the Diabetes Prevention Program (DPP), lifestyle intervention with diet and exercise training significantly lowered the rate of progression from IGT to diabetes, and was particularly effective in older people. The mechanisms of lifestyle changes to prevent diabetes and the effects on beta-cell function remain unclear. Exercise is well-known to increase insulin sensitivity, although exercise effects on beta-cell function have not been specifically assessed. In a pilot study supported by local VA funds, one week of aerobic exercise training improved insulin sensitivity as expected, but also improved beta-cell function in sedentary older people with IGT, with no change in body weight/composition, fasting glucose or lipid/inflammatory parameters.
Based on my current VA RCDA project and the pilot study results, this VA CDA-2 proposal will test in detail the novel overall hypothesis that lifestyle intervention with aerobic exercise training leads to improved beta-cell function in human age-related glucose intolerance. The potential mechanisms of the age-associated decline in beta-cell function and whereby exercise training may improve beta-cell function will also be explored. Beta-cell function will be examined in relation to expected improvements in insulin sensitivity, and the effects of exercise will be isolated with weight maintenance and nutritional balance. The time course of exercise effects over three months, the acute and chronic effects of exercise training on beta-cell function, the effects of high vs. low intensity exercise training, and different important components of beta-cell function will be examined. The interaction between exercise training effects on beta-cell function in older people with IGT and potential mediators including free fatty acids (FFA)/FFA composition, intraabdominal fat, adipocytokines, and incretin hormones will be examined.
In light of the striking effectiveness of the DPP lifestyle intervention to prevent diabetes in older people with IGT, the decline in beta-cell function with even normal human aging, and the importance of beta-cell dysfunction in the progression to diabetes, it is of great interest to further define the potential, novel metabolic effects of exercise training on beta-cell function, particularly in the aging population. This project may provide initial steps to further determine the mechanisms whereby lifestyle changes prevent diabetes. This would provide critical information needed to translate research findings into clinical practice in order to prevent diabetes in the aging veteran population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: ExerciseExercise |
| 2 | Active comparator | Behavioral: ExerciseExercise |
| 3 | No intervention | –Control |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sedentary (defined as activity level of no more than occasional short bouts of walking per week), community-dwelling older veterans and non-veterans age 60-80 years. Special recruitment efforts will focus on enrollment of veterans.
- Fasting glucose <126 mg/dl and 2-hr glucose 140-199 mg/dl (IGT) during OGTT.
- BMI 26-36 kg/m2.
Key exclusion criteria (10 listed)
- Current use of oral anti-diabetic agents, insulin, systemic steroids, beta-blockers, thiazides.
- Abnormal screening exercise stress test: exercise-induced sustained arrhythmia, symptomatic myocardial ischemia, ischemic EKG changes (>2mm ST-T depression in non Q-wave lead) during screening maximum treadmill test.
- Clinically significant cardiac disease defined as congestive heart failure (CHF) requiring pharmacologic therapy or New York Heart Association (NYHA) Class 3 or 4 cardiac status, atrial fibrillation, symptomatic obstructive valvular disease, high-grade AV block, unstable angina, or myocardial infarction within the last 12 months.
- Participation in a physical therapy, exercise or diet program.
- Significant orthopedic or musculoskeletal conditions.
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 |
|---|---|---|
| ExerciseExercise | Behavioural | 1, 2 |
Primary outcome
Exercise effect on beta-cell function at 3 months
Time frame: 3 months
1 secondary outcome
Exercise effects glucose tolerance, intraabdominal fat, lipids, glycerol, GLP-1, adiponectin, and leptin.
Time frame: 3 months
Results and safety
The study was stopped early (reason given: PI left the VA, per Central Office). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Aging and Glucose Intolerance, run by US Department of Veterans Affairs.
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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 11 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: PI left the VA, per Central Office). Results are not available in the source record.
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?
Exercise effect on beta-cell function at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2011.