Vascular Reparative Mechanism in Diabetes

NCT02119689 | Active Not Recruiting

• 2 other identifiers: 1308798827R01HL110170
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy

Keywords

Diabetes; Retinopathy

Outcome Measures

Primary Outcomes (1)

• The ACE/ACE2 ratio within EPC's

  Peripheral blood of 150cc, approximately 8-10 tablespoons will be collected from a vein in the arm of both diabetic and healthy control patients.

  up to 216 weeks

Secondary Outcomes (1)

• The balance of the RAS (renin-angiotensin system) within EPCs

  up to 216 weeks

Other Outcomes (2)

• Photography findings

  up to 216 weeks

• Fluorescein angiogram findings

  up to 216 weeks

Study Arms (2)

Diabetic Patients

Mild, Moderate and Severe Retinopathy

Other: Diabetic Patients

Healthy Controls

Age and sex matched Healthy Controls

Other: Healthy Controls

Interventions

Diabetic Patients OTHER

measuring CD34 cell function in relation to diabetic retinopathy status

Diabetic Patients

Healthy Controls OTHER

measuring CD34 cell function

Healthy Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Ophthalmology and Primary Care Clinics

You may qualify if:

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

You may not qualify if:

• Current pregnancy as evidence by a urine pregnancy test as the blood from a pregnant female will influence the results of the laboratory tests

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus; Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Maria B Grant, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: April 22, 2014
• Study Start: October 30, 2011
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

US (1)