Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT00133718
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2005-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A 2 Year Trial of Patients With Type 2 Diabetes Focusing on Cardiovascular Diagnostics and Metabolic Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patients were randomized to intensive care of standard care, outcomes were assessed by experts who where unaware of group allocation'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2012-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-23', 'studyFirstSubmitDate': '2005-08-23', 'studyFirstSubmitQcDate': '2005-08-23', 'lastUpdatePostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in 10-year absolute CHD risk', 'timeFrame': '2-year'}], 'secondaryOutcomes': [{'measure': 'Effects on cardiovascular events', 'timeFrame': '5-year'}, {'measure': 'Effects on hospitalisations', 'timeFrame': '5-year'}, {'measure': 'Effects on CV risk markers (HbA1c, lipids, blood pressure, inflammation, etc)', 'timeFrame': '2 years and 5 years'}, {'measure': 'Effects on health related quality of life', 'timeFrame': '2 years and 5 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 2 diabetes mellitus', 'Cardiovascular', 'Coronary artery disease', 'Glycemic control', 'Treatment', 'Diabetes Mellitus'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '25173538', 'type': 'BACKGROUND', 'citation': 'Ofstad AP, Johansen OE, Gullestad L, Birkeland KI, Orvik E, Fagerland MW, Urheim S, Aakhus S. Neutral impact on systolic and diastolic cardiac function of 2 years of intensified multi-intervention in type 2 diabetes: the randomized controlled Asker and Baerum Cardiovascular Diabetes (ABCD) study. Am Heart J. 2014 Sep;168(3):280-288.e2. doi: 10.1016/j.ahj.2014.03.026. Epub 2014 Jun 9.'}, {'pmid': '26573616', 'type': 'BACKGROUND', 'citation': 'Ulimoen GR, Ofstad AP, Endresen K, Gullestad L, Johansen OE, Borthne A. Low-dose CT coronary angiography for assessment of coronary artery disease in patients with type 2 diabetes--a cross-sectional study. BMC Cardiovasc Disord. 2015 Nov 14;15:147. doi: 10.1186/s12872-015-0143-9.'}, {'pmid': '17532067', 'type': 'BACKGROUND', 'citation': 'Johansen OE, Bjuro T, Endresen K, Blaasaas KG, Birkeland K, Aakhus S, Gullestad L. Heart rate adjustments and analysis of recovery patterns of ST-segment depression in type 2 diabetes. Int J Cardiol. 2008 Jun 23;127(1):129-32. doi: 10.1016/j.ijcard.2007.04.022. Epub 2007 May 25.'}, {'pmid': '17454845', 'type': 'BACKGROUND', 'citation': 'Johansen OE, Birkeland KI, Orvik E, Flesland O, Wergeland R, Ueland T, Smith C, Endresen K, Aukrust P, Gullestad L. Inflammation and coronary angiography in asymptomatic type 2 diabetic subjects. Scand J Clin Lab Invest. 2007;67(3):306-16. doi: 10.1080/00365510601045088.'}, {'pmid': '23987834', 'type': 'BACKGROUND', 'citation': 'Ofstad AP, Gullestad L, Orvik E, Aakhus S, Endresen K, Ueland T, Aukrust P, Fagerland MW, Birkeland KI, Johansen OE. Interleukin-6 and activin A are independently associated with cardiovascular events and mortality in type 2 diabetes: the prospective Asker and Baerum Cardiovascular Diabetes (ABCD) cohort study. Cardiovasc Diabetol. 2013 Aug 30;12:126. doi: 10.1186/1475-2840-12-126.'}, {'pmid': '17509068', 'type': 'RESULT', 'citation': 'Johansen OE, Gullestad L, Blaasaas KG, Orvik E, Birkeland KI. Effects of structured hospital-based care compared with standard care for Type 2 diabetes-The Asker and Baerum Cardiovascular Diabetes Study, a randomized trial. Diabet Med. 2007 Sep;24(9):1019-27. doi: 10.1111/j.1464-5491.2007.02198.x. Epub 2007 May 17.'}, {'pmid': '30851727', 'type': 'DERIVED', 'citation': 'Arora S, Ofstad AP, Ulimoen GR, Birkeland KI, Endresen K, Gullestad L, Johansen OE. Asymptomatic coronary artery disease in a Norwegian cohort with type 2 diabetes: a prospective angiographic study with intravascular ultrasound evaluation. Cardiovasc Diabetol. 2019 Mar 9;18(1):26. doi: 10.1186/s12933-019-0832-2.'}, {'pmid': '28627980', 'type': 'DERIVED', 'citation': 'Ofstad AP, Ulimoen GR, Orvik E, Birkeland KI, Gullestad LL, Fagerland MW, Johansen OE. Long-term follow-up of a hospital-based, multi-intervention programme in type 2 diabetes mellitus: impact on cardiovascular events and death. J Int Med Res. 2017 Oct;45(5):1535-1552. doi: 10.1177/0300060517707674. Epub 2017 Jun 19.'}]}, 'descriptionModule': {'briefSummary': 'The purposes of this study are:\n\n* to investigate the extent of cardiovascular complications in a representative cohort (n=135) of adult patients with type 2 diabetes;\n* to examine if modern non-invasive assessment can replace invasive assessment;\n* to determine the effects of a 6 month lifestyle interventional program on weight, glycemic control and lipids in 60 patients;\n* to determine the effect of a 2-year prospective, randomised multi-interventional program (n=120) on cardiovascular risk, anthropometric measures and glycometabolic control; and\n* to investigate inflammatory markers in this setting.', 'detailedDescription': 'As cardiovascular disease often is silent in type 2 diabetic patients, ways of detecting this early is of potential benefit, as is probably an aggressive treatment regimen trying to achieve goals for factors such as blood pressure, glycemic control, lipids, smoking, physical activity and weight.\n\nThis study compares traditional non-invasive tests such as stress-ecg, modern non-invasive tests such as holter-analysis, modern ECG analysis, stress-ecco cardiography and tissue Doppler against the gold standard today for assessing coronary artery disease, coronary angiography, in patients with type 2 diabetes and at least one cv-risk factor (i.e smoking, premature familial coronary artery disease (CAD)), hypertension) irrespective of symptoms or signs of CAD.\n\nThe participants are included in a randomized-control trial for 2 years where one arm receives standard treatment and one receives treatment after a multi-interventional program.\n\nEnd-points include: glycemic control, lipid control, weight control, blood pressure control, and effects on inflammatory parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* Ages 18-75 years\n* Men and women\n* At least one cardiovascular risk factor (i.e hypertension, dyslipidemia, smoking/formerly smoker, premature familial coronary artery disease \\[CAD\\], microalbuminuria)\n* Written informed consent given\n\nExclusion Criteria:\n\n* Unwillingness\n* Age \\< 18 or \\> 75 years\n* Unstable cardiovascular condition\n* Unstable medical condition'}, 'identificationModule': {'nctId': 'NCT00133718', 'briefTitle': 'A 2 Year Trial of Patients With Type 2 Diabetes Focusing on Cardiovascular Diagnostics and Metabolic Control', 'organization': {'class': 'OTHER', 'fullName': 'Asker & Baerum Hospital'}, 'officialTitle': 'Asker and Baerum Cardiovascular Diabetes Study', 'orgStudyIdInfo': {'id': 'ABCD-study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Structured multi intervention', 'description': 'Structured multi intervention to reach predefined glycemic and blood pressure goals as well as activity and weight goal', 'interventionNames': ['Drug: Combined lifestyle intervention and optimisation of pharmacological treatment']}, {'type': 'OTHER', 'label': 'Standard of care', 'description': 'Standard care with or without structured care according to national guidelines', 'interventionNames': ['Drug: Combined lifestyle intervention and optimisation of pharmacological treatment']}], 'interventions': [{'name': 'Combined lifestyle intervention and optimisation of pharmacological treatment', 'type': 'DRUG', 'otherNames': ['Combination of drugs (predefined) to reach treatment targets'], 'description': '1. 6 months non-pharmacological treatment, 18 months with polypharmacy for glucose control (metformin, repaglinide/glimepiride, pioglitazone or insulin)\n2. standard care', 'armGroupLabels': ['Standard of care', 'Structured multi intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1309', 'city': 'Rud', 'country': 'Norway', 'facility': 'Asker and Baerum Hospital, Medical Department', 'geoPoint': {'lat': 60.43333, 'lon': 11.63333}}], 'overallOfficials': [{'name': 'Odd E Johansen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asker and Baerum Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asker & Baerum Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rikshospitalet University Hospital', 'class': 'OTHER'}, {'name': 'University Hospital, Aker', 'class': 'OTHER'}, {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study director', 'investigatorFullName': 'Odd Erik Johansen', 'investigatorAffiliation': 'Asker & Baerum Hospital'}}}}