Vascular Reparative Mechanism in Diabetes

Active, not recruiting

• Conditions: Diabetic Retinopathy
• Interventions: Other: Diabetic Patients; Other: Healthy Controls

• Registration Number: NCT02119689
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-10-30
• Study First Submitted: 2014-04-14
• Study First Submitted QC: 2014-04-21
• Study First Posted: 2014-04-22
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 78

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetic Patients	Diabetic Patients	Mild, Moderate and Severe Retinopathy
Healthy Controls	Healthy Controls	Age and sex matched Healthy Controls

Primary Outcome Measures

Name	Time	Method
The ACE/ACE2 ratio within EPC's	up to 216 weeks	Peripheral blood of 150cc, approximately 8-10 tablespoons will be collected from a vein in the arm of both diabetic and healthy control patients.

Secondary Outcome Measures

Name	Time	Method
The balance of the RAS (renin-angiotensin system) within EPCs	up to 216 weeks	The Endo-PAT2000 will be used to obtain this measurement. This is a 15-minute office-based test where a blood-pressure cuff is placed around the arm, inflated and measurements are obtained from a small fingertip monitor

Trial Locations

Locations (1)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States