Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT00742456
Status:
COMPLETED
Last Update Posted:
2011-02-23
First Post:
2008-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Microvascular Dilatation After Endogenous Induced Hyperinsulinemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-22', 'studyFirstSubmitDate': '2008-08-26', 'studyFirstSubmitQcDate': '2008-08-26', 'lastUpdatePostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional recruitment of capillaries in the skin.', 'timeFrame': 'January 2009 - January 2010'}], 'secondaryOutcomes': [{'measure': 'Perfused capillary density in the nailfold.', 'timeFrame': 'January 2009 - January 2010'}, {'measure': 'Endothelium- (in)dependent vasodilatation of finger skin microcirculation', 'timeFrame': 'January 2009 - January 2010'}, {'measure': 'Density of arterioles, capillaries and venules in the bulbar conjunctiva.', 'timeFrame': 'January 2009 - January 2010'}, {'measure': 'Diameter of arterioles and venules in the bulbar conjunctiva.', 'timeFrame': 'January 2009 - January 2010'}, {'measure': 'Insulin sensitivity (HOMA-IR)', 'timeFrame': 'January 2009 - January 2010'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Microcirculation', 'Insulin', 'Hypertension', 'Obesity'], 'conditions': ['Hypertension', 'Obesity']}, 'descriptionModule': {'briefSummary': 'In this study we will examine if the insulin-induced microvascular effects will occur after a physiological stimulus (i.e. a oral glucose tolerance test). With that the physiological importance of the insulin-induced microvascular dilatation can be elucidated. In this study we hypothesize that oral glucose intake and consequently the endogenous induced hyperinsulinemia will lead to insulin-induced microvascular dilatation in healthy normotensive subjects. Furthermore, we suggest that the insulin-mediated microvascular dilatation, resulting from this physiological induced hyperinsulinemia, will be less in hypertensive and obese subjects compared to healthy controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nhealthy normotensive subjects:\n\n1. 18-60 years\n2. Caucasian\n3. Blood pressure \\<140/90 mmHg\n\nobese normotensive subjects:\n\n1. 18-60 years\n2. Caucasian\n3. Blood pressure \\<140/90 mmHg\n4. BMI 30-38kg/m2\n\nhypertensive subjects:\n\n1. 18-60 years\n2. Caucasian\n3. Untreated hypertension \\>140/90mmHg.\n\nExclusion Criteria for healthy normotensive and hypertensive subjects:\n\n1. Obesity (BMI\\>27kg/m2)\n2. Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, heart failure)\n3. 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\n\nfor normotensive obese subjects:\n\n1. Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, heart failure)\n2. Impaired glucose tolerance or diabetes mellitus according to the criteria of the ADA\n3. Smoking\n4. Alcohol use \\>4U/day\n5. Use of medication (antihypertensive drugs, lipid lowering drugs, corticosteroids, NNSAIDs)\n6. Pregnancy\n7. Wearing contact lenses'}, 'identificationModule': {'nctId': 'NCT00742456', 'briefTitle': 'Microvascular Dilatation After Endogenous Induced Hyperinsulinemia', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Insulin-induced Microvascular Dilatation During a Physiological Stimulus - Studies in Hypertension and Obesity.', 'orgStudyIdInfo': {'id': '08-2-031 MEC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'I', 'description': 'Glucose', 'interventionNames': ['Dietary Supplement: Glucose solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'II', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Glucose solution', 'type': 'DIETARY_SUPPLEMENT', 'description': 'single oral intake of 250 ml glucose solution (75gr sugar in 250ml of water)', 'armGroupLabels': ['I']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'single intake of placebo solution (250ml of sweet flavored water, no sugar added), orally', 'armGroupLabels': ['II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6202 AZ', 'city': 'Maastricht', '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'}}}}