Philadelphia, Pennsylvania 19140


Purpose:

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.


Study summary:

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.


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).


Study is Available At:


Original ID:

22531


NCT ID:

NCT02326259


Secondary ID:


Study Acronym:


Brief Title:

Evaluation of Progression of Diabetic Retinopathy With Rapid Correction of Hyperglycemia


Official Title:

Evaluation of Progression of Diabetic Retinopathy With Rapid Correction of Hyperglycemia


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Temple University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

30


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:William J Foster, MD, PhD
Principal Investigator
Temple University
Primary Contact:Ajay Rao, MD
ajay.rao@temple.edu
Backup Contact:William J Foster, MD, PhD
855-250-3937
DrFoster@WilliamFosterMD.com

Study Dates

Start Date:March 2015
Completion Date:March 2018
Completion Type:Anticipated
Primary Completion Date:March 2018
Primary Completion Type:Anticipated
Verification Date:May 2017
Last Changed Date:May 1, 2017
First Received Date:December 22, 2014

Study Outcomes

Outcome Type:Primary Outcome
Measure:Progression of diabetic retinopathy
Time Frame:90 days
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:Initiation of treatment of diabetes
Description:Treatment of diabetes according to the standard of care.

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Temple University

Samples and Retentions

Study Population: Patients being seen in the endocrinology clinic at Temple University Hospital.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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