Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-30 @ 9:21 AM
Study NCT ID:
NCT00742066
Status:
UNKNOWN
Last Update Posted:
2011-03-17
First Post:
2008-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of AT1-receptor Blockers in Insulin-induced Vasodilation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077405', 'term': 'Irbesartan'}, {'id': 'D015736', 'term': 'Felodipine'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013141', 'term': 'Spiro Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2009-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-03-16', 'studyFirstSubmitDate': '2008-08-26', 'studyFirstSubmitQcDate': '2008-08-26', 'lastUpdatePostDateStruct': {'date': '2011-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'functional recruitment of capillaries in the skin', 'timeFrame': 'July 2009'}], 'secondaryOutcomes': [{'measure': 'perfused capillary density in the nailfold', 'timeFrame': 'July 2009'}, {'measure': 'Endothelium- (in)dependent vasodilatation of finger skin microcirculation', 'timeFrame': 'July 2009'}, {'measure': 'Density of arterioles, capillaries and venules in the bulbar conjunctiva.', 'timeFrame': 'July 2009'}, {'measure': 'Diameter of arterioles and venules in the bulbar conjunctiva', 'timeFrame': 'July 2009'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Insulin resistance', 'Microcirculation', 'Angiotensin II receptor blocker'], 'conditions': ['Hypertension', 'Insulin Resistance', 'Microcirculation']}, 'descriptionModule': {'briefSummary': 'In this study we hypothesize that blocking the angiotensin II AT1-receptor improves the insulin-induced microvascular dilatation. Objectives: 1. Does blockade of the angiotensin II AT1-receptor improve the insulin-induced microvascular effects in hypertensive patients. 2. Does blockade of the angiotensin II AT1-receptor impair the insulin-induced microvascular effects in normotensive control subjects?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nhypertensive subjects:\n\n1. 18-60 years\n2. Caucasian\n3. untreated hypertension \\>140/90mmHg.\n\nnormotensive subjects:\n\n1. 18-60 years\n2. Caucasian\n3. Blood pressure \\<140/90 mmHg.\n\nExclusion Criteria:\n\n1. Obesity (BMI\\>27kg/m2)\n2. Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, heart failure)\n3. Impaired glucose tolerance or diabetes mellitus according to the criteria of the ADA\n4. Smoking\n5. Alcohol use \\>4U/day\n6. Use of medication (antihypertensive drugs, lipid lowering drugs, corticosteroids, NNSAIDs)\n7. Pregnancy\n8. Wearing contact lenses'}, 'identificationModule': {'nctId': 'NCT00742066', 'briefTitle': 'Role of AT1-receptor Blockers in Insulin-induced Vasodilation.', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Insulin-induced Microvascular Activity in Patients With Essential Hypertension: a Possible Role for Angiotensin II AT1-receptor Blockers.', 'orgStudyIdInfo': {'id': 'MEC 07-2-115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'I', 'description': 'Irbesartan', 'interventionNames': ['Drug: Irbesartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'II', 'description': 'Felodipine', 'interventionNames': ['Drug: Felodipine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'III', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Irbesartan', 'type': 'DRUG', 'otherNames': ['Aprovel C09CA04'], 'description': 'Single dose 600mg orally', 'armGroupLabels': ['I']}, {'name': 'Felodipine', 'type': 'DRUG', 'otherNames': ['Plendil C08CA02'], 'description': 'single dose 10mg Felodipine ER', 'armGroupLabels': ['II']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Single dose tablet orally', 'armGroupLabels': ['III']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6202 AZ', 'city': 'Maastricht', 'state': 'P.O. Box 5800', 'country': 'Netherlands', 'facility': 'University Hospital Maastricht', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'CDA Stehouwer, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Univeristy Hospital Maastricht'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. CDA Stehouwer', 'oldOrganization': 'University Hospital Maastricht'}}}}