Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2026-03-29 @ 10:31 PM
Study NCT ID:
NCT00497003
Status:
COMPLETED
Last Update Posted:
2007-10-15
First Post:
2007-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Beta Blocker Treatment on Endothelial Function in Patients With Type 2 Diabetes or Chronic Heart Failure
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': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000077261', 'term': 'Carvedilol'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-07', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-10-12', 'studyFirstSubmitDate': '2007-07-05', 'studyFirstSubmitQcDate': '2007-07-05', 'lastUpdatePostDateStruct': {'date': '2007-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelial function and insulin stimulated endothelial function', 'timeFrame': '2 months'}], 'secondaryOutcomes': [{'measure': 'Insulin stimulated glucose uptake', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Endothelial function', 'Beta blocker', 'Type 2 diabetes', 'Chronic heart failure'], 'conditions': ['Endothelial Function', 'Beta Blocker']}, 'referencesModule': {'references': [{'pmid': '21999413', 'type': 'DERIVED', 'citation': 'Falskov B, Hermann TS, Raunso J, Christiansen B, Rask-Madsen C, Major-Pedersen A, Kober L, Torp-Pedersen C, Dominguez H. Endothelial function is unaffected by changing between carvedilol and metoprolol in patients with heart failure--a randomized study. Cardiovasc Diabetol. 2011 Oct 15;10:91. doi: 10.1186/1475-2840-10-91.'}, {'pmid': '20500877', 'type': 'DERIVED', 'citation': 'Kveiborg B, Hermann TS, Major-Pedersen A, Christiansen B, Rask-Madsen C, Raunso J, Kober L, Torp-Pedersen C, Dominguez H. Metoprolol compared to carvedilol deteriorates insulin-stimulated endothelial function in patients with type 2 diabetes - a randomized study. Cardiovasc Diabetol. 2010 May 25;9:21. doi: 10.1186/1475-2840-9-21.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effect of the two different beta blockers metoprolol and carvedilol on endothelial function in patients with either type two diabetes or chronic heart failure.\n\nHypothesis: 1\\* Carvedilol compared to metoprolol has a favourable effect on endothelial function.\n\n2\\* Carvedilol compared to metoprolol has a favourable effect on insulin stimulated endothelial function.\n\nThe study is conducted as an open parallel group study. Endothelial function and insulin stimulated endothelial function was evaluated before and after a two months treatment period with either of the two beta blockers.', 'detailedDescription': 'Endothelial function is deteriorated in patients with type 2 diabetes and in patients with chronic heart failure. Treatment with carvedilol improves survival in patients with chronic heart failure compared to treatment with metoprolol. Carvedilol improves metabolic glucose control in patients with diabetes compared to metoprolol.Carvedilol compared to metoprolol also decreases the number of patients with new onset diabetes among patients with chronic heart failure. The mechanism behind these findings has not been fully understood.\n\nThe purpose of this study is to investigate if carvedilol compared to metoprolol has a favourable effect on endothelial function and insulin stimulated endothelial function, in groups of patients with either diabetes or chronic heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* Chronic heart failure\n\nExclusion Criteria:\n\n* For patients with type 2 diabetes:\n\n \\* Vascular complications.\n* For patients with chronic heart failure:\n\n * Severe uncontrolled heart failure.\n * Untreated severe hypertension, hypotension.\n * Bradycardia.\n * Known intolerance to beta blocker treatment.\n * Pregnancy,'}, 'identificationModule': {'nctId': 'NCT00497003', 'briefTitle': 'Effect of Beta Blocker Treatment on Endothelial Function in Patients With Type 2 Diabetes or Chronic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'orgStudyIdInfo': {'id': 'KF 02-071/03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Treatment with either metoprolol or carvedilol', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Cardiology, University Hospital of Copenhagen, Bispebjerg', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Christian Torp-Pedersen, MD, DSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiology, Bispebjerg Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danish Heart Foundation', 'class': 'OTHER'}]}}}