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

April 11, 2023 updated by: Steven J. Prior, Ph.D., Baltimore VA Medical Center

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Baltimore VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endothelial progenitor cell number
Time Frame: Baseline
Baseline
Endothelial progenitor cell number
Time Frame: 6-month
6-month
Skeletal muscle capillarization
Time Frame: Baseline
Baseline
Skeletal muscle capillarization
Time Frame: 6-month
6-month

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiorespiratory Fitness
Time Frame: Baseline
Baseline
Cardiorespiratory Fitness
Time Frame: 6-month
6-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baltimore VA Medical Center

Collaborators

University of Maryland, Baltimore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2011

Primary Completion (Actual)

December 31, 2021

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

August 5, 2010

First Submitted That Met QC Criteria

August 5, 2010

First Posted (Estimate)

August 6, 2010

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00047188

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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