Evaluation of Progression of Diabetic Retinopathy With Rapid Correction of Hyperglycemia

NCT ID: NCT02326259

Last Updated: 2022-08-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2022-03-31

Brief Summary

The investigators are doing this research for two reasons. The first is to see how the retina (back of your eye) changes when your blood sugar is treated with medication for the first time. This will help us better understand the progression of a condition known as Diabetic Retinopathy. The second reason is to provide diabetic blood samples, which will possibly help identify biomarkers for diabetic retinopathy. Biomarkers are things that indicate the presence of a specific condition, and indicate a higher likelihood of developing that condition.

Detailed Description

The goal of this research is to conduct a study that investigates (1) how diabetic retinopathy progresses when poorly controlled Type 2 diabetic patients initiate intensive blood sugar control and (2) to determine if there are biomarkers that predict progression of diabetic retinopathy. Typically, the retina is thought to undergo rapid progression of diabetic retinopathy, although this has been poorly characterized in a formal study.

The first goal will be quantified by taking initial photos of the retina with the Pictor Plus hand-held fundus camera, as well as monthly photos (when the patient is scheduled for their endocrinology appointments, throughout a 90 day period). The second goal will be accomplished by testing the patient's blood. There will be an initial blood withdraw, as well as blood withdraws at monthly intervals throughout the same 90 day period as the fundus photos.

This study will help us to understand the pathogenesis of diabetic retinopathy, as well as potentially lead to an improved understanding of progression of diabetic retinopathy.

Conditions

Diabetic Retinopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Initiation of treatment of diabetes

Treatment of diabetes according to the standard of care.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Presenting to the endocrinology clinic with a hemoglobin A1c of greater than 12.

Exclusion Criteria

• Patients with other ocular or systemic conditions, including macular degeneration, uveitis, glaucoma, and autoimmune conditions (Rheumatoid Arthritis, Lupus, and other similar conditions).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William J Foster, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Ajay D Rao, MD, MMSc, FACP

Role: PRINCIPAL_INVESTIGATOR

Temple University

Raul A DeLa Cadena, MD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

Temple University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

22531

Identifier Type: -

Identifier Source: org_study_id