Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT01626469
Status:
UNKNOWN
Last Update Posted:
2019-08-01
First Post:
2012-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Measurement of Eye Blood Flow and Renal Function in Healthy and Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002216', 'term': 'Captopril'}], 'ancestors': [{'id': 'D011392', 'term': 'Proline'}, {'id': 'D007098', 'term': 'Imino Acids'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-30', 'studyFirstSubmitDate': '2012-06-19', 'studyFirstSubmitQcDate': '2012-06-20', 'lastUpdatePostDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in ophthalmic artery blood flow from baseline', 'timeFrame': '1 hour post drug, 2 hours post drug, 3 hours post drug', 'description': 'Eye blood flow will be measured at baseline and post drug time points (3 total)'}], 'secondaryOutcomes': [{'measure': 'Change in blood pressure from baseline', 'timeFrame': 'Every 15 minutes for 3 hours', 'description': 'Blood pressure will be monitored throughout the study starting at baseline'}, {'measure': 'Change in renal plasma flow (RPF) from baseline', 'timeFrame': '1 hour post drug, 2 hours post drug, 3 hours post drug', 'description': 'Renal Plasma Flow (to measure kidney function) will be measured at baseline and post drug time points (3 total)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to the determine the effect of salt intake and Captopril on the ophthalmic artery (OA) blood supply of individuals with Type 2 Diabetes Mellitus.', 'detailedDescription': 'The overall objective of this study is to ascertain if salt intake affects ophthalmic artery (OA) blood flow. In addition, we will study both the eye and kidney response to ACE inhibition compared to placebo while controlling salt intake in subjects with Type 2 diabetes mellitus.\n\nWe hypothesize that salt intake will affect OA blood flow.\n\nWe will initially look at both eye and renal response to subjects on a low salt diet (10mEq Na/day) followed by response to high salt diet (200mEq Na/day). In addition, we may look at eye response while subjects consume their regular diet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 Diabetes Mellitus\n\nExclusion Criteria:\n\n* Type 1 Diabetes Mellitus\n* Heart Attack or Stroke within the last 6 months\n* Pregnant or lactating females'}, 'identificationModule': {'nctId': 'NCT01626469', 'briefTitle': 'Measurement of Eye Blood Flow and Renal Function in Healthy and Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Eye Blood Flow and the Kidney', 'orgStudyIdInfo': {'id': '2011P002805'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A', 'description': 'Captopril 25 mg (Admission 1, Day 1, low salt diet) Matched Placebo (Admission 1, Day 2, low salt diet) Captopril 25 mg (Admission 2, Day 1, high salt diet) Matched Placebo (Admission 2, Day 2, high salt diet)', 'interventionNames': ['Drug: Captopril', 'Drug: placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Captopril', 'description': 'Matched Placebo (Admission 1, Day 1, low salt diet) Captopril 25 mg (Admission 1, Day 2, low salt diet) Matched Placebo (Admission 2, Day 1, high salt diet) Captopril 25 mg (Admission 2, Day 2, high salt diet)', 'interventionNames': ['Drug: Captopril', 'Drug: placebo']}], 'interventions': [{'name': 'Captopril', 'type': 'DRUG', 'description': '25mg Captopril', 'armGroupLabels': ['Arm A', 'Captopril']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['Arm A', 'Captopril']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Ebrahim Barkoudah, M.D.,M.P.H.', 'role': 'CONTACT', 'email': 'ebarkoudah@partners.org', 'phone': '617-732-6901'}], 'overallOfficials': [{'name': 'Norman K Hollenberg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}, {'name': 'Ebrahim Barkoudah, M.D.,M.P.H.', 'role': 'STUDY_DIRECTOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Physiologic Research Division, Department of Radiology', 'investigatorFullName': 'Norman K. Hollenberg, MD, PhD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}