Exercise Endothelial Progenitor Cells (EPCs) and Type 2 D... | NCT01176578

Studies
Exercise Endothelial Progenitor Cells (EPCs) and Type 2 Diabetes

NCT01176578

Sponsor

Baltimore VA Medical Center

Status

Active, not recruiting

Last Update Posted

Sep 19, 2025Actual

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Type 2 Diabetes Mellitus

Interventions

Aerobic Exercise Training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Aug 5, 2010

First Submission Date that Met QC Criteria

Aug 5, 2010

First Posted Date

Aug 6, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2025

Last Update Posted Date

Sep 19, 2025Actual

Name	Class
University of Maryland, Baltimore	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Aerobic Exercise Training	Other	6 months of aerobic exercise training, 3 days per week	IGT NGT T2DM

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Cardiorespiratory Fitness		Baseline
Cardiorespiratory Fitness		6-month

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Baltimore VA Medical Center		Baltimore	Maryland	21201	United States

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided