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Evaluation of Progression of Diabetic Retinopathy With Rapid Correction of Hyperglycemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02326259
Recruitment Status : Unknown
Verified May 2017 by Temple University.
Recruitment status was:  Recruiting
First Posted : December 29, 2014
Last Update Posted : May 3, 2017
Information provided by (Responsible Party):
Temple University

Tracking Information
First Submitted Date December 22, 2014
First Posted Date December 29, 2014
Last Update Posted Date May 3, 2017
Study Start Date March 2015
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 26, 2014)
Progression of diabetic retinopathy [ Time Frame: 90 days ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02326259 on Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients being seen in the endocrinology clinic at Temple University Hospital.
Condition Diabetic Retinopathy
Intervention Other: Initiation of treatment of diabetes
Treatment of diabetes according to the standard of care.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 26, 2014)
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2018
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
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).
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT02326259
Other Study ID Numbers 22531
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Temple University
Study Sponsor Temple University
Collaborators Not Provided
Principal Investigator: William J Foster, MD, PhD Temple University
Principal Investigator: Ajay D Rao, MD, MMSc, FACP Temple University
Principal Investigator: Raul A DeLa Cadena, MD Temple University
PRS Account Temple University
Verification Date May 2017