Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2026-02-04 @ 3:47 AM
Study NCT ID:
NCT02326259
Status:
COMPLETED
Last Update Posted:
2022-08-12
First Post:
2014-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Progression of Diabetic Retinopathy With Rapid Correction of Hyperglycemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}, {'id': 'D018450', 'term': 'Disease Progression'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-11', 'studyFirstSubmitDate': '2014-12-22', 'studyFirstSubmitQcDate': '2014-12-26', 'lastUpdatePostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression of diabetic retinopathy', 'timeFrame': '90 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetic Retinopathy', 'Disease Progression'], 'conditions': ['Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients being seen in the endocrinology clinic at Temple University Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presenting to the endocrinology clinic with a hemoglobin A1c of greater than 12.\n\nExclusion Criteria:\n\n* Patients with other ocular or systemic conditions, including macular degeneration, uveitis, glaucoma, and autoimmune conditions (Rheumatoid Arthritis, Lupus, and other similar conditions).'}, 'identificationModule': {'nctId': 'NCT02326259', 'briefTitle': 'Evaluation of Progression of Diabetic Retinopathy With Rapid Correction of Hyperglycemia', 'organization': {'class': 'OTHER', 'fullName': 'Temple University'}, 'officialTitle': 'Evaluation of Progression of Diabetic Retinopathy With Rapid Correction of Hyperglycemia', 'orgStudyIdInfo': {'id': '22531'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Initiation of treatment of diabetes', 'type': 'OTHER', 'description': 'Treatment of diabetes according to the standard of care.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'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', 'affiliation': 'Temple University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Temple University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}