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Evaluation of Progression of Diabetic Retinopathy With Rapid Correction of Hyperglycemia

Evaluation of Progression of Diabetic Retinopathy With Rapid Correction of Hyperglycemia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02326259
Enrollment
20
Registered
2014-12-29
Start date
2015-03-31
Completion date
2022-03-31
Last updated
2022-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

Keywords

Diabetic Retinopathy, Disease Progression

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.

Interventions

OTHERInitiation of treatment of diabetes

Treatment of diabetes according to the standard of care.

Sponsors

Temple University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
Progression of diabetic retinopathy90 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026