Vascular Reparative Mechanism in Diabetes

NCT ID: NCT02119689

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-30

Study Completion Date

2026-12-31

Brief Summary

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The purpose of this research study is to study blood stem cells in diabetic patients and normal patients. We would like to better understand if these cells, called endothelial precursor cells (EPCs), are not working as expected in people with diabetes. We would like to see if the function of these cells can predict the development of diabetic retinopathy.

Diabetic retinopathy is an eye disease associated with diabetes in which the cells of the retina are damaged. It can cause blurred vision, vision loss, blindness or possible bleeding in the retina. Even with current treatments, the quality of life for people with diabetic retinopathy is much reduced.

Detailed Description

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Conditions

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Diabetic Retinopathy

Keywords

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Diabetes Retinopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetic Patients

Mild, Moderate and Severe Retinopathy

Diabetic Patients

Intervention Type OTHER

measuring CD34 cell function in relation to diabetic retinopathy status

Healthy Controls

Age and sex matched Healthy Controls

Healthy Controls

Intervention Type OTHER

measuring CD34 cell function

Interventions

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Diabetic Patients

measuring CD34 cell function in relation to diabetic retinopathy status

Intervention Type OTHER

Healthy Controls

measuring CD34 cell function

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Men or women 18 years or older
* 39 type 1 or type 2 diabetic patients
* 13 with mild retinopathy
* 13 with moderate retinopathy
* 13 with severe, nonproliferative retinopathy
* 39 age and sex matched healthy controls

Exclusion Criteria

* Current pregnancy as evidence by a urine pregnancy test as the blood from a pregnant female will influence the results of the laboratory tests
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Maria Grant

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria B Grant, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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R01HL110170

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1308798827

Identifier Type: -

Identifier Source: org_study_id