Exercise Endothelial Progenitor Cells (EPCs) and Type 2 Diabetes (EPC-DM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Baltimore VA Medical Center
Sponsor:
Collaborator:
University of Maryland
Information provided by (Responsible Party):
Steven J. Prior, Ph.D., Baltimore VA Medical Center
ClinicalTrials.gov Identifier:
NCT01176578
First received: August 5, 2010
Last updated: June 27, 2013
Last verified: June 2013

August 5, 2010
June 27, 2013
July 2011
September 2013   (final data collection date for primary outcome measure)
  • Endothelial progenitor cell number [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Endothelial progenitor cell number [ Time Frame: 6-month ] [ Designated as safety issue: No ]
  • Skeletal muscle capillarization [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Skeletal muscle capillarization [ Time Frame: 6-month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01176578 on ClinicalTrials.gov Archive Site
  • Cardiorespiratory Fitness [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Cardiorespiratory Fitness [ Time Frame: 6-month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Exercise Endothelial Progenitor Cells (EPCs) and Type 2 Diabetes
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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Type 2 Diabetes Mellitus
Other: Aerobic Exercise Training
6 months of aerobic exercise training, 3 days per week
  • Experimental: T2DM
    Type 2 Diabetes Mellitus
    Intervention: Other: Aerobic Exercise Training
  • Experimental: IGT
    Impaired Glucose Tolerance
    Intervention: Other: Aerobic Exercise Training
  • Active Comparator: NGT
    Normal Glucose Tolerance
    Intervention: Other: Aerobic Exercise Training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
Not Provided
September 2013   (final data collection date for primary outcome measure)

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
Both
50 Years to 80 Years
Yes
Contact: Sarah Horlitz, MS 410-605-7000 ext 4823 sarah.horlitz@va.gov
United States
 
NCT01176578
HP-00047188
Yes
Steven J. Prior, Ph.D., Baltimore VA Medical Center
Baltimore VA Medical Center
University of Maryland
Not Provided
Baltimore VA Medical Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP