Type 2 Diabetes MellitusEPC-DMNCT01176578
Exercise Endothelial Progenitor Cells (EPCs) and Type 2 Diabetes
A study testing Aerobic Exercise Training in people with Type 2 Diabetes Mellitus, run by Baltimore VA Medical Center at 1 site in United States.
Trial summary
The discovery of the role of endothelial progenitor cells (EPCs) and their involvement in the cardiovascular complications of type 2 diabetes (T2DM) would quickly have a significant impact on the millions of Americans who have T2DM. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Aerobic Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50-80
- Non-smoker
- If woman, postmenopausal >1 year
Who cannot join
- History of heart disease or stroke
- Cancer
- Poorly controlled hypertension or dyslipidemia
- Kidney or Liver diseases
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center
Baltimore, Maryland, 21201
About this study
Official title: Exercise Training, CACs, and Vascular Function in Older Veterans With IGT (Impaired Glucose Tolerance)
The discovery of the role of endothelial progenitor cells (EPCs) and their involvement in the cardiovascular complications of type 2 diabetes (T2DM) would quickly have a significant impact on the millions of Americans who have T2DM. This project is designed to 1) determine the mechanisms underlying EPC dysfunction in older, sedentary adults with T2DM compared those with normal glucose metabolism and impaired glucose metabolism, and 2) determine if aerobic exercise training is an efficacious therapy for EPC dysfunction in T2DM, and whether improvement in EPC number and function translates to improved endothelial function, increased capillarization, and improved glucose metabolism in T2DM.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Aerobic Exercise Training
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise TrainingOther
6 months of aerobic exercise training, 3 days per week
| Study group | Role | What they receive |
|---|---|---|
| T2DM | Experimental | Type 2 Diabetes Mellitus Receives: Other: Aerobic Exercise Training |
| IGT | Experimental | Impaired Glucose Tolerance Receives: Other: Aerobic Exercise Training |
| NGT | Active comparator | Normal Glucose Tolerance Receives: Other: Aerobic Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial progenitor cell number
Measured: Baseline
Endothelial progenitor cell number
Measured: 6-month
Skeletal muscle capillarization
Measured: Baseline
Skeletal muscle capillarization
Measured: 6-month
Secondary outcomes (2)
Cardiorespiratory Fitness
Measured: Baseline
Cardiorespiratory Fitness
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startJul 2011
- Primary completion31 Dec 2021
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baltimore VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- University of Maryland, Baltimore
- Responsible party
- Principal investigator, Steven J. Prior, Ph.D., Baltimore VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176578
- Sponsor's protocol ID
- HP-00047188
- Acronym
- EPC-DM
- Status last verified
- Sep 2025
- First submitted
- 5 Aug 2010
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training, CACs, and Vascular Function in Older Veterans With IGT (Impaired Glucose Tolerance)
- ClinicalTrials.gov ID
- NCT01176578
- Acronym / sponsor ID
- EPC-DM / HP-00047188
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Baltimore VA Medical CenterUS federal agency
- Collaborators
- University of Maryland, Baltimore
- Study start
- Jul 2011 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Aug 2010 (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.
The discovery of the role of endothelial progenitor cells (EPCs) and their involvement in the cardiovascular complications of type 2 diabetes (T2DM) would quickly have a significant impact on the millions of Americans who have T2DM. This project is designed to 1) determine the mechanisms underlying EPC dysfunction in older, sedentary adults with T2DM compared those with normal glucose metabolism and impaired glucose metabolism, and 2) determine if aerobic exercise training is an efficacious therapy for EPC dysfunction in T2DM, and whether improvement in EPC number and function translates to improved endothelial function, increased capillarization, and improved glucose metabolism in T2DM.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T2DM | Experimental | Other: Aerobic Exercise TrainingType 2 Diabetes Mellitus |
| IGT | Experimental | Other: Aerobic Exercise TrainingImpaired Glucose Tolerance |
| NGT | Active comparator | Other: Aerobic Exercise TrainingNormal Glucose Tolerance |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 50-80
- Non-smoker
- If woman, postmenopausal >1 year
Key exclusion criteria (4 listed)
- History of heart disease or stroke
- Cancer
- Poorly controlled hypertension or dyslipidemia
- Kidney or Liver diseases
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 Training6 months of aerobic exercise training, 3 days per week | Other | IGT, NGT, T2DM |
Primary outcome
Endothelial progenitor cell number
Time frame: Baseline
Endothelial progenitor cell number
Time frame: 6-month
Skeletal muscle capillarization
Time frame: Baseline
Skeletal muscle capillarization
Time frame: 6-month
2 secondary outcomes
Cardiorespiratory Fitness
Time frame: Baseline
Cardiorespiratory Fitness
Time frame: 6-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
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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.
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 in people with Type 2 Diabetes Mellitus, run by Baltimore VA Medical Center 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 4 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: under way, not looking for participants, as of the sponsor's last update on 19 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Endothelial progenitor cell number (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?
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 19 Sep 2025; AzTrials last refreshed its copy on 31 Oct 2026.