Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-31 @ 9:50 AM
Study NCT ID:
NCT03017703
Status:
COMPLETED
Last Update Posted:
2021-06-02
First Post:
2017-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Aldosterone in Circulatory Disorders Within Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077545', 'term': 'Eplerenone'}], 'ancestors': [{'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-28', 'studyFirstSubmitDate': '2017-01-02', 'studyFirstSubmitQcDate': '2017-01-09', 'lastUpdatePostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vascular function', 'timeFrame': '8 weeks', 'description': 'Femoral arterial blood flow in response to femoral arterially infused ACh'}, {'measure': 'Insulin sensitivity measured by a insulin clamp', 'timeFrame': '8 weeks', 'description': 'Glucose infusion rate during euglycaemic-hyperinsulinaemic clamp'}], 'secondaryOutcomes': [{'measure': 'Vascular function', 'timeFrame': '8 weeks', 'description': 'Microperfusion performed on blood vessels in vitro obtained from muscle biopsies'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Endothelial dysfunction', 'Insulin resistance', 'Type 2 diabetes', 'Mineralocorticoid blocker'], 'conditions': ['Endothelial Dysfunction', 'Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '34350730', 'type': 'DERIVED', 'citation': 'Finsen SH, Hansen MR, Hoffmann-Petersen J, Hojgaard HF, Mortensen SP. Eight weeks of mineralocorticoid blockade does not improve insulin sensitivity in type 2 diabetes. Physiol Rep. 2021 Aug;9(15):e14971. doi: 10.14814/phy2.14971.'}, {'pmid': '33247722', 'type': 'DERIVED', 'citation': 'Finsen SH, Hansen MR, Hansen PBL, Mortensen SP. Aldosterone Induces Vasoconstriction in Individuals with Type 2 Diabetes: Effect of Acute Antioxidant Administration. J Clin Endocrinol Metab. 2021 Mar 8;106(3):e1262-e1270. doi: 10.1210/clinem/dgaa867.'}]}, 'descriptionModule': {'briefSummary': 'The importance of Aldosterone for endothelial function and Insulin resistance observed within patients with type 2 diabetes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed diabetic \\< 5 Yrs.\n* BMI \\< 32 kg/m2\n* Non-smoking\n* Blood pressure \\< 140/90 mmHg (treatment with maximum of two antihypertensive drugs)\n\nExclusion Criteria:\n\n* Insulin treatment\n* Hypertension (\\>140/90 mmHg)\n* Sequelae to diabetes\n* Smoking\n* Known chronic diseases\n* Pregnancy or birth within 3 month\n* Alcohol misuse'}, 'identificationModule': {'nctId': 'NCT03017703', 'briefTitle': 'The Role of Aldosterone in Circulatory Disorders Within Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'The Role of Aldosterone in Diabetes Related Vascular Disease, a New Therapeutic Target?', 'orgStudyIdInfo': {'id': 'H- 15007940'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Type 2 Diabetes', 'description': '8 weeks of treatment with Aldosterone blocker Eplerenone', 'interventionNames': ['Drug: Eplerenone']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy', 'description': '8 weeks of treatment with Aldosterone blocker Eplerenone', 'interventionNames': ['Drug: Eplerenone']}], 'interventions': [{'name': 'Eplerenone', 'type': 'DRUG', 'armGroupLabels': ['Healthy', 'Type 2 Diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Cardiovascular and Renal Research', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Stefan P Mortensen, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Stefan Mortensen', 'investigatorAffiliation': 'University of Southern Denmark'}}}}