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Clinical Trial NCT01176578 (EPC-DM) for Type 2 Diabetes Mellitus is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Exercise Endothelial Progenitor Cells (EPCs) and Type 2 Diabetes (EPC-DM)
Clinical Trial NCT01176578 (EPC-DM) is an interventional study for Type 2 Diabetes Mellitus that is active, not recruiting. It started on 1 July 2011 with plans to enroll 70 participants. Led by Baltimore VA Medical Center, it is expected to complete by 31 December 2026. The latest data from ClinicalTrials.gov was last updated on 19 September 2025.
Brief 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. 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.
Official Title
Exercise Training, CACs, and Vascular Function in Older Veterans With IGT (Impaired Glucose Tolerance)
Conditions
TYPE 2 Diabetes MellitusOther Study IDs
- EPC-DM
- HP-00047188
NCT ID Number
Start Date (Actual)
2011-07
Last Update Posted
2025-09-19
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
70
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Primary Purpose
Prevention
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalT2DM Type 2 Diabetes Mellitus | Aerobic Exercise Training 6 months of aerobic exercise training, 3 days per week |
ExperimentalIGT Impaired Glucose Tolerance | Aerobic Exercise Training 6 months of aerobic exercise training, 3 days per week |
Active ComparatorNGT Normal Glucose Tolerance | Aerobic Exercise Training 6 months of aerobic exercise training, 3 days per week |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Endothelial progenitor cell number | Baseline | |
Endothelial progenitor cell number | 6-month | |
Skeletal muscle capillarization | Baseline | |
Skeletal muscle capillarization | 6-month |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Cardiorespiratory Fitness | Baseline | |
Cardiorespiratory Fitness | 6-month |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
50 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- Age 50-80
- Non-smoker
- If woman, postmenopausal >1 year
- History of heart disease or stroke
- Cancer
- Poorly controlled hypertension or dyslipidemia
- Kidney or Liver diseases
Study Responsible Party
Steven J. Prior, Ph.D., Principal Investigator, Assistant Professor, Baltimore VA Medical Center
No contact data.
1 Study Locations in 1 Countries
Maryland
Baltimore VA Medical Center, Baltimore, Maryland, 21201, United States