Clinical trial NCT02326259: Evaluation of Progression of Diabetic Retinopathy With Rapid Correction of Hyperglycemia
Official title: Evaluation of Progression of Diabetic Retinopathy With Rapid Correction of Hyperglycemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Keywords: Diabetic Retinopathy
Disease Progression
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2014-12-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being seen in the endocrinology clinic at Temple University Hospital.

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.

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).

Primary outcomes:
measure: Progression of diabetic retinopathy
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: Temple University
name: William J Foster, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Temple University
name: Ajay D Rao, MD, MMSc, FACP
role: PRINCIPAL_INVESTIGATOR
affiliation: Temple University
name: Raul A DeLa Cadena, MD
role: PRINCIPAL_INVESTIGATOR
References: