NCT01176578

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes-mellitus

Timeline
8mo left

Started Jul 2011

Longer than P75 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jul 2011Dec 2026

First Submitted

Initial submission to the registry

August 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2010

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

10.5 years

First QC Date

August 5, 2010

Last Update Submit

September 18, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Endothelial progenitor cell number

    Baseline

  • Endothelial progenitor cell number

    6-month

  • Skeletal muscle capillarization

    Baseline

  • Skeletal muscle capillarization

    6-month

Secondary Outcomes (2)

  • Cardiorespiratory Fitness

    Baseline

  • Cardiorespiratory Fitness

    6-month

Study Arms (3)

T2DM

EXPERIMENTAL

Type 2 Diabetes Mellitus

Other: Aerobic Exercise Training

IGT

EXPERIMENTAL

Impaired Glucose Tolerance

Other: Aerobic Exercise Training

NGT

ACTIVE COMPARATOR

Normal Glucose Tolerance

Other: Aerobic Exercise Training

Interventions

6 months of aerobic exercise training, 3 days per week

IGTNGTT2DM

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 50-80
  • Non-smoker
  • If woman, postmenopausal \>1 year

You may not qualify if:

  • History of heart disease or stroke
  • Cancer
  • Poorly controlled hypertension or dyslipidemia
  • Kidney or Liver diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 5, 2010

First Posted

August 6, 2010

Study Start

July 1, 2011

Primary Completion

December 31, 2021

Study Completion (Estimated)

December 31, 2026

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations