Evaluation of Progression of Diabetic Retinopathy With Rapid Correction of Hyperglycemia

Diabetic Retinopathy Clinical Trial

Official title:

Evaluation of Progression of Diabetic Retinopathy With Rapid Correction of Hyperglycemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02326259
• Other study ID #: 22531
• Status: Completed
• Start date: March 2015
• Est. completion date: March 2022

Study information

• Verified date: August 2022
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Disease Progression
• Hyperglycemia
• Retinal Diseases

Intervention

Other:
• Initiation of treatment of diabetes
Treatment of diabetes according to the standard of care.

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of diabetic retinopathy		90 days