Vascular Reparative Mechanism in Diabetes

Diabetic Retinopathy Clinical Trial

— RAAS  

Official title:

Vascular Reparative Mechanism by ACE2/Ang-(1-7) in Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02119689
• Other study ID #: 1308798827
• Status: Active, not recruiting
• Start date: October 30, 2011
• Est. completion date: October 30, 2024

Study information

• Verified date: August 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 78
• Est. completion date: October 30, 2024
• Est. primary completion date: October 9, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Other:
• Diabetic Patients
measuring CD34 cell function in relation to diabetic retinopathy status
• Healthy Controls
measuring CD34 cell function

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Photography findings	The findings from eye photographs will be collected and evaluated from both the diabetic patients and the heallthy control patients. This will be done at either the patient's yearly visit or at their 6 week follow-up visit.	up to 216 weeks
Other	Fluorescein angiogram findings	The findings from eye photographs will be collected and evaluated from both the diabetic patients and the heallthy control patients. This will be done at either the patient's yearly visit or at their 6 week follow-up visit.	up to 216 weeks
Primary	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	The balance of the RAS (renin-angiotensin system) within EPCs	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	up to 216 weeks