Type 2 Diabetes MellitusNCT00701051
Exercise Training and Glucose Metabolism in Aging
A study testing Aerobic exercise training and Detraining (cessation of exercise) in people with Type 2 Diabetes Mellitus and Impaired Glucose Tolerance (Prediabetes), run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Diabetes and its associated complications affect more than 20 million Americans, and the prevalence of type 2 diabetes and impaired glucose tolerance rises dramatically with age such that 40% of Americans over age 60 are affected. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Impaired Glucose Tolerance (Prediabetes)
- What is being tested?
- Aerobic exercise training and Detraining (cessation of 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
- 1 siteUnited States
- Study dates
- Oct 2006to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50-75 years
- Non-smoker >2 years
- Body mass index = 18-35 kg/m2
Who cannot join
- History of CAD or cerebrovascular disease that would preclude exercise
- Implantable defibrillator
- Active cancer
- Chronic pulmonary, thyroid, renal, liver, or hematological disease
- HIV positive or prone to malnutrition
- Sickle cell anemia
Show all 15Show fewer
- Type 1 diabetes, or currently on medication to treat type 2 diabetes
- Poorly-controlled type 2 diabetes
- Poorly-controlled hypertension
- Taking medications including: beta-blockers, oral steroids, warfarin, certain statins, hormone replacement therapy (HRT), oral contraceptives (OCP), thiazolidinediones (TZD), or chronic steroids or nonsteroidal analgesics (NSAIDS) that may not be safely discontinued temporarily for specific procedures (i.e. for 72 hours prior)
- Allergic to lidocaine or heparin
- Recent weight change (>5kg in 3 months)
- Currently pregnant or nursing
- Physical impairment limiting exercise
- Dementia or unstable clinical depression
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, 21201
About this study
Official title: Aging, Angiogenesis and Metabolic Responses to Aerobic Exercise
Diabetes and its associated complications affect more than 20 million Americans, and the prevalence of type 2 diabetes and impaired glucose tolerance rises dramatically with age such that 40% of Americans over age 60 are affected. In older adults, glucose metabolism may be affected by reduced skeletal muscle capillary supply, which limits insulin, glucose, and oxygen delivery to skeletal muscle. Reduced capillary supply to skeletal muscle is found in older individuals with impaired glucose tolerance and we hypothesize that this is due to reduced vascular growth factor expression, and chronic inflammation. Further, we hypothesize that reversal of a sedentary lifestyle through aerobic exercise training will increase insulin signaling and vascular growth factor expression, as well as decrease inflammation, to increase capillary supply to skeletal muscle, which contributes to improved glucose metabolism in older adults. This study will: 1) Determine the mechanisms underlying reduced skeletal muscle capillarization in older adults with impaired glucose tolerance; and 2) Determine the effect of aerobic exercise training-induced increases in skeletal muscle capillarization on glucose metabolism in older adults.
- Being tested
- Aerobic exercise training, Detraining (cessation of exercise)
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise trainingBehavioural
24 weeks of aerobic exercise training: 3 times per week, 60 minutes per session, at 70% of maximal aerobic capacity
Detraining (cessation of exercise)Behavioural
Cessation of exercise for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Older adults, normal glucose tolerance Receives: Behavioral: Aerobic exercise training; Behavioral: Detraining (cessation of exercise) |
| Arm 2 | Experimental | Older adults, impaired glucose tolerance Receives: Behavioral: Aerobic exercise training; Behavioral: Detraining (cessation of exercise) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Glucose Utilization
Insulin-stimulated glucose uptake
Measured: baseline
Glucose Utilization (Pre/Post Intervention)
Insulin-stimulated glucose uptake
Measured: baseline, 24 weeks, 26 weeks
Baseline Skeletal Muscle Capillarization
Measured: baseline
Skeletal Muscle Capillarization (Pre/Post Intervention)
Measured: baseline, 24 weeks, 26 weeks
Secondary outcomes (5)
Baseline 2-hour Postprandial Glucose
Measured: baseline
2-hr Post-prandial Plasma Glucose Level
Measured: baseline, 24 weeks, 26 weeks
Baseline Cardiorespiratory Fitness
maximal oxygen consumption
Measured: baseline
Cardiorespiratory Fitness
Maximal oxygen consumption
Measured: baseline, 24 weeks, 26 weeks
Body Composition (%Fat)
Measured: baseline, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startOct 2006
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- University of Maryland, National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Steven J. Prior, PhD, Principal investigator, VA Maryland Health Care System, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701051
- Sponsor's protocol ID
- CDA-2-039-08S
- Other IDs
- H-27940, 5P30AG028747-05
- Status last verified
- Mar 2015
- First submitted
- 18 Jun 2008
- Last updated
- 6 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Prior SJ, Goldberg AP, Ortmeyer HK, Chin ER, Chen D, Blumenthal JB, Ryan AS. Increased Skeletal Muscle Capillarization Independently Enhances Insulin Sensitivity in Older Adults After Exercise Training and Detraining. Diabetes. 2015 Oct;64(10):3386-95. doi: 10.2337/db14-1771. Epub 2015 Jun 11.
PubMed 26068543
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aging, Angiogenesis and Metabolic Responses to Aerobic Exercise
- ClinicalTrials.gov ID
- NCT00701051
- Acronym / sponsor ID
- CDA-2-039-08S
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- University of Maryland, National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- Oct 2006
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 19 Jun 2008 (estimated)
- Results
- Posted 6 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetes and its associated complications affect more than 20 million Americans, and the prevalence of type 2 diabetes and impaired glucose tolerance rises dramatically with age such that 40% of Americans over age 60 are affected. In older adults, glucose metabolism may be affected by reduced skeletal muscle capillary supply, which limits insulin, glucose, and oxygen delivery to skeletal muscle. Reduced capillary supply to skeletal muscle is found in older individuals with impaired glucose tolerance and we hypothesize that this is due to reduced vascular growth factor expression, and chronic inflammation. Further, we hypothesize that reversal of a sedentary lifestyle through aerobic exercise training will increase insulin signaling and vascular growth factor expression, as well as decrease inflammation, to increase capillary supply to skeletal muscle, which contributes to improved glucose metabolism in older adults. This study will: 1) Determine the mechanisms underlying reduced skeletal muscle capillarization in older adults with impaired glucose tolerance; and 2) Determine the effect of aerobic exercise training-induced increases in skeletal muscle capillarization on glucose metabolism in older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Behavioral: Aerobic exercise training, Behavioral: Detraining (cessation of exercise)Older adults, normal glucose tolerance |
| Arm 2 | Experimental | Behavioral: Aerobic exercise training, Behavioral: Detraining (cessation of exercise)Older adults, impaired glucose tolerance |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 50-75 years
- Non-smoker >2 years
- Body mass index = 18-35 kg/m2
Key exclusion criteria (15 listed)
- History of CAD or cerebrovascular disease that would preclude exercise
- Implantable defibrillator
- Active cancer
- Chronic pulmonary, thyroid, renal, liver, or hematological disease
- HIV positive or prone to malnutrition
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 |
|---|---|---|
| Aerobic exercise training24 weeks of aerobic exercise training: 3 times per week, 60 minutes per session, at 70% of maximal aerobic capacity | Behavioural | Arm 1, Arm 2 |
| Detraining (cessation of exercise)Cessation of exercise for 2 weeks | Behavioural | Arm 1, Arm 2 |
Primary outcome
Baseline Glucose Utilization
Time frame: baseline
Insulin-stimulated glucose uptake
Glucose Utilization (Pre/Post Intervention)
Time frame: baseline, 24 weeks, 26 weeks
Insulin-stimulated glucose uptake
Baseline Skeletal Muscle Capillarization
Time frame: baseline
Skeletal Muscle Capillarization (Pre/Post Intervention)
Time frame: baseline, 24 weeks, 26 weeks
5 secondary outcomes
Baseline 2-hour Postprandial Glucose
Time frame: baseline
2-hr Post-prandial Plasma Glucose Level
Time frame: baseline, 24 weeks, 26 weeks
Baseline Cardiorespiratory Fitness
Time frame: baseline
Cardiorespiratory Fitness
Time frame: baseline, 24 weeks, 26 weeks
Body Composition (%Fat)
Time frame: baseline, 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26068543Prior SJ, Goldberg AP, Ortmeyer HK, Chin ER, Chen D, Blumenthal JB, Ryan AS. Increased Skeletal Muscle Capillarization Independently Enhances Insulin Sensitivity in Older Adults After Exercise Training and Detraining. Diabetes. 2015 Oct;64(10):3386-95. doi: 10.2337/db14-1771. Epub 2015 Jun 11.
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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.
Steven J. Prior, PhD principal investigator
VA Maryland Health Care System, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise training and Detraining (cessation of exercise) in people with Type 2 Diabetes Mellitus and Impaired Glucose Tolerance (Prediabetes), run by US Department of Veterans Affairs 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 3 inclusion and 15 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 6 Apr 2015. 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?
Yes. Results are posted in the registry (first posted 6 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Baseline Glucose Utilization (time frame: baseline). The study lists 4 primary outcomes in all. 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 NCT00701051, 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 6 Apr 2015.