Exercise Endothelial Progenitor Cells (EPCs) and Type 2 Diabetes
EPC-DM
Exercise Training, CACs, and Vascular Function in Older Veterans With IGT (Impaired Glucose Tolerance)
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes-mellitus
Started Jul 2011
Longer than P75 for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2010
CompletedFirst Posted
Study publicly available on registry
August 6, 2010
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedSeptember 19, 2025
September 1, 2025
10.5 years
August 5, 2010
September 18, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Endothelial progenitor cell number
Baseline
Endothelial progenitor cell number
6-month
Skeletal muscle capillarization
Baseline
Skeletal muscle capillarization
6-month
Secondary Outcomes (2)
Cardiorespiratory Fitness
Baseline
Cardiorespiratory Fitness
6-month
Study Arms (3)
T2DM
EXPERIMENTALType 2 Diabetes Mellitus
IGT
EXPERIMENTALImpaired Glucose Tolerance
NGT
ACTIVE COMPARATORNormal Glucose Tolerance
Interventions
Eligibility Criteria
You may qualify if:
- Age 50-80
- Non-smoker
- If woman, postmenopausal \>1 year
You may not qualify if:
- History of heart disease or stroke
- Cancer
- Poorly controlled hypertension or dyslipidemia
- Kidney or Liver diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baltimore VA Medical Centerlead
- University of Maryland, Baltimorecollaborator
Study Sites (1)
Baltimore VA Medical Center
Baltimore, Maryland, 21201, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 5, 2010
First Posted
August 6, 2010
Study Start
July 1, 2011
Primary Completion
December 31, 2021
Study Completion (Estimated)
December 31, 2026
Last Updated
September 19, 2025
Record last verified: 2025-09