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

This study is currently recruiting participants.
Verified July 2011 by Baltimore VA Medical Center
Sponsor:
Collaborator:
University of Maryland
Information provided by:
Baltimore VA Medical Center
ClinicalTrials.gov Identifier:
NCT01176578
First received: August 5, 2010
Last updated: July 21, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
 Other: Aerobic Exercise Training

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of Exercise on the Regulation of EPCs in Obesity, Insulin Resistance, and Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baltimore VA Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Cardiorespiratory Fitness [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Cardiorespiratory Fitness [ Time Frame: 6-month ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: July 2011
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: T2DM
Type 2 Diabetes Mellitus
 Other: Aerobic Exercise Training
6 months of aerobic exercise training, 3 days per week
Experimental: IGT
Impaired Glucose Tolerance
 Other: Aerobic Exercise Training
6 months of aerobic exercise training, 3 days per week
Active Comparator: NGT
Normal Glucose Tolerance
 Other: Aerobic Exercise Training
6 months of aerobic exercise training, 3 days per week

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176578

Contacts
Contact: Sarah Horlitz, MS 410-605-7000 ext 4823 sarah.horlitz@va.gov

Locations
United States, Maryland
Baltimore VA Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Sarah Horlitz, MS     410-605-7000 ext 4823     sarah.horlitz@va.gov    
Principal Investigator: Steven J Prior, Ph.D.            
Sponsors and Collaborators
Baltimore VA Medical Center
University of Maryland
  More Information

No publications provided

Responsible Party: Steven J. Prior, Ph.D., University of Maryland School of Medicine
ClinicalTrials.gov Identifier: NCT01176578     History of Changes
Other Study ID Numbers: HP-00047188
Study First Received: August 5, 2010
Last Updated: July 21, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013