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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02326259
Recruitment Status : Recruiting
First Posted : December 29, 2014
Last Update Posted : May 3, 2017
Information provided by (Responsible Party):
Temple University

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.

Condition or disease Intervention/treatment
Diabetic Retinopathy Other: Initiation of treatment of diabetes

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Progression of Diabetic Retinopathy With Rapid Correction of Hyperglycemia
Study Start Date : March 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Progression of diabetic retinopathy [ Time Frame: 90 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients being seen in the endocrinology clinic at Temple University Hospital.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02326259

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Contact: Ajay Rao, MD
Contact: William J Foster, MD, PhD 855-250-3937

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United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Martin Schardt, BS    215-707-3185   
Contact: William J Foster, MD, PhD    215-707-3185   
Sponsors and Collaborators
Temple University
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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

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Responsible Party: Temple University Identifier: NCT02326259     History of Changes
Other Study ID Numbers: 22531
First Posted: December 29, 2014    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by Temple University:
Diabetic Retinopathy
Disease Progression

Additional relevant MeSH terms:
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Disease Progression
Retinal Diseases
Diabetic Retinopathy
Disease Attributes
Pathologic Processes
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases