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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic Exercise Training
Sponsored by
Baltimore VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes Mellitus

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Baltimore VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

T2DM

IGT

NGT

Arm Description

Type 2 Diabetes Mellitus

Impaired Glucose Tolerance

Normal Glucose Tolerance

Outcomes

Primary Outcome Measures

Endothelial progenitor cell number
Endothelial progenitor cell number
Skeletal muscle capillarization
Skeletal muscle capillarization

Secondary Outcome Measures

Cardiorespiratory Fitness
Cardiorespiratory Fitness

Full Information

First Posted
August 5, 2010
Last Updated
April 11, 2023
Sponsor
Baltimore VA Medical Center
Collaborators
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT01176578
Brief Title
Exercise Endothelial Progenitor Cells (EPCs) and Type 2 Diabetes
Acronym
EPC-DM
Official Title
Exercise Training, CACs, and Vascular Function in Older Veterans With IGT (Impaired Glucose Tolerance)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2011 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baltimore VA Medical Center
Collaborators
University of Maryland, Baltimore

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
T2DM
Arm Type
Experimental
Arm Description
Type 2 Diabetes Mellitus
Arm Title
IGT
Arm Type
Experimental
Arm Description
Impaired Glucose Tolerance
Arm Title
NGT
Arm Type
Active Comparator
Arm Description
Normal Glucose Tolerance
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise Training
Intervention Description
6 months of aerobic exercise training, 3 days per week
Primary Outcome Measure Information:
Title
Endothelial progenitor cell number
Time Frame
Baseline
Title
Endothelial progenitor cell number
Time Frame
6-month
Title
Skeletal muscle capillarization
Time Frame
Baseline
Title
Skeletal muscle capillarization
Time Frame
6-month
Secondary Outcome Measure Information:
Title
Cardiorespiratory Fitness
Time Frame
Baseline
Title
Cardiorespiratory Fitness
Time Frame
6-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Baltimore VA Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

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Exercise Endothelial Progenitor Cells (EPCs) and Type 2 Diabetes

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