We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01176578
Recruitment Status : Recruiting
First Posted : August 6, 2010
Last Update Posted : May 2, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Other: Aerobic Exercise Training

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Exercise Training, CACs, and Vascular Function in Older Veterans With IGT (Impaired Glucose Tolerance)
Study Start Date : July 2011
Estimated Primary Completion Date : September 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Endothelial progenitor cell number [ Time Frame: Baseline ]
  2. Endothelial progenitor cell number [ Time Frame: 6-month ]
  3. Skeletal muscle capillarization [ Time Frame: Baseline ]
  4. Skeletal muscle capillarization [ Time Frame: 6-month ]

Secondary Outcome Measures :
  1. Cardiorespiratory Fitness [ Time Frame: Baseline ]
  2. Cardiorespiratory Fitness [ Time Frame: 6-month ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01176578


Contacts
Contact: Kim Dormer, MS 410-605-7000 ext 4130 kimberly.dormer@va.gov

Locations
United States, Maryland
Baltimore VA Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Kim Dormer, MS    410-605-7000 ext 4130    kimberly.dormer@va.gov   
Principal Investigator: Steven J Prior, Ph.D.         
Sponsors and Collaborators
Baltimore VA Medical Center
University of Maryland
More Information

Responsible Party: Steven J. Prior, Ph.D., Assistant Professor, Baltimore VA Medical Center
ClinicalTrials.gov Identifier: NCT01176578     History of Changes
Other Study ID Numbers: HP-00047188
First Posted: August 6, 2010    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017

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