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NCT01176578 Clinical Trial

Exercise Endothelial Progenitor Cells (EPCs) and Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

— EPC-DM  

Official title:
Exercise Training, CACs, and Vascular Function in Older Veterans With IGT (Impaired Glucose Tolerance)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01176578
Other study ID # HP-00047188
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 2011
Est. completion date December 31, 2024

Study information
Verified date April 2023
Source Baltimore VA Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 70
Est. completion date December 31, 2024
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria: - Age 50-80 - Non-smoker - If woman, postmenopausal >1 year Exclusion Criteria: - History of heart disease or stroke - Cancer - Poorly controlled hypertension or dyslipidemia - Kidney or Liver diseases

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Aerobic Exercise Training
6 months of aerobic exercise training, 3 days per week

Locations
Country Name City State
United States Baltimore VA Medical Center Baltimore Maryland

Sponsors (2)
Lead Sponsor Collaborator
Baltimore VA Medical Center University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Endothelial progenitor cell number Baseline
Primary Endothelial progenitor cell number 6-month
Primary Skeletal muscle capillarization Baseline
Primary Skeletal muscle capillarization 6-month
Secondary Cardiorespiratory Fitness Baseline
Secondary Cardiorespiratory Fitness 6-month
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