RAAS: Vascular Reparative Mechanism in Diabetes

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02119689

Collaborator

(none)

Enrollment

Location

144

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy	Other: Diabetic Patients Other: Healthy Controls

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

78 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 30, 2011

Actual Primary Completion Date :

Oct 9, 2019

Anticipated Study Completion Date :

Oct 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Diabetic Patients Mild, Moderate and Severe Retinopathy	Other: Diabetic Patients measuring CD34 cell function in relation to diabetic retinopathy status
Healthy Controls Age and sex matched Healthy Controls	Other: Healthy Controls measuring CD34 cell function

Arm

Intervention/Treatment

Diabetic Patients

Mild, Moderate and Severe Retinopathy

Other: Diabetic Patients

measuring CD34 cell function in relation to diabetic retinopathy status

Healthy Controls

Age and sex matched Healthy Controls

Other: Healthy Controls

measuring CD34 cell function

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Photography findings [up to 216 weeks]
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.
Fluorescein angiogram findings [up to 216 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

Principal Investigator: Maria B Grant, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maria Grant, Professor, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT02119689

Other Study ID Numbers:

1308798827

First Posted:

Apr 22, 2014

Last Update Posted:

Aug 15, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Maria Grant, Professor, University of Alabama at Birmingham

Diabetes

Retinopathy

Additional relevant MeSH terms:

Retinal Diseases

Diabetic Retinopathy

Study Results

No Results Posted as of Aug 15, 2022