Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-26 @ 9:23 PM
Study NCT ID:
NCT01119404
Status:
UNKNOWN
Last Update Posted:
2010-05-11
First Post:
2010-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hämeenlinna Metabolic Syndrome Research Program: Surrogate Indicators for Atherosclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D007172', 'term': 'Erectile Dysfunction'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum, EDTA plasma, citrate plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-05-10', 'studyFirstSubmitDate': '2010-05-06', 'studyFirstSubmitQcDate': '2010-05-06', 'lastUpdatePostDateStruct': {'date': '2010-05-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metabolic Syndrome', 'Coronary Heart Disease', 'Erectile Dysfunction', 'Arterial Elasticity', 'Oxidized Low Density Lipoprotein', 'Cardiovascular Diseases', 'Risk Assessment', 'Endothelial Dysfunction', 'Diabetes Mellitus', 'Surrogate Markers', 'Risk Factors'], 'conditions': ['Metabolic Syndrome', 'Coronary Heart Disease']}, 'referencesModule': {'references': [{'pmid': '38491429', 'type': 'DERIVED', 'citation': 'Saarinen HJ, Lahtela J, Mahonen P, Palomaki A; Hameenlinna Metabolic Syndrome Research Program Study Group. The association between inflammation, arterial stiffness, oxidized LDL and cardiovascular disease in Finnish men with metabolic syndrome - a 15-year follow-up study. BMC Cardiovasc Disord. 2024 Mar 15;24(1):162. doi: 10.1186/s12872-024-03818-x.'}, {'pmid': '21726125', 'type': 'DERIVED', 'citation': 'Pohjantahti-Maaroos H, Palomaki A, Kankkunen P, Husgafvel S, Knuth T, Vesterinen K, Oksanen K. Arterial elasticity and oxidized LDL among men with metabolic syndrome and different 10-year cardiovascular risk estimated by FINRISK and SCORE models. Ann Med. 2012 Aug;44(5):503-12. doi: 10.3109/07853890.2011.590520. Epub 2011 Jul 4.'}, {'pmid': '21707993', 'type': 'DERIVED', 'citation': 'Pohjantahti-Maaroos H, Palomaki A, Hartikainen J. Erectile dysfunction, physical activity and metabolic syndrome: differences in markers of atherosclerosis. BMC Cardiovasc Disord. 2011 Jun 27;11:36. doi: 10.1186/1471-2261-11-36.'}]}, 'descriptionModule': {'briefSummary': 'Mechanisms that link metabolic syndrome to atherosclerosis are incompletely understood. As a part of Hämeenlinna Metabolic Syndrome Research Program (HMS) surrogate indicators for atherosclerosis are studied in 120 men with metabolic syndrome, 120 men with coronary heart disease and 80 physically active controls and in different settings.', 'detailedDescription': 'Accumulation of oxidized low-density lipoproteins (LDL) in the intimae of arteries together with risk factors known to enhance atherosclerosis, damage the endothelium of the arterial wall. Dysfunction of the endothelium leads into loss of elasticity of the artery. Surrogate indicators of atherosclerosis might be seen already in the early phase of otherwise subclinical arterial disease.\n\nIn this study, we investigate calculated risk of the subjects (SCORE, FINRISK, Framingham score), platelet function and surrogate indicators for atherosclerosis like erectile dysfunction, plasma levels of oxidized LDL, arterial elasticity and biochemical markers for endothelial damage and dysfunction in different settings (case-only and case-control).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGroup 1: Metabolic syndrome\n\n* 120 Finnish men with metabolic syndrome (MetS) defined according to National Cholesterol Education Program (NCEP) Adult Treatment Panel III\n* MetS diagnosed in routine health examination and laboratory tests\n* Age: 30 to 65 years\n\nGroup 2: Coronary heart disease (CHD)\n\n* 120 Finnish men with angiographically proven CHD\n* Age: 30 to 65 years\n\nGroup 3: Control\n\n* 80 Finnish men\n* Exercising physically more than three times a week and more than 30 minutes per exercise on regular basis\n* Never been studied or treated because of cardiovascular disease\n* Age: 30 to 65 years'}, 'identificationModule': {'nctId': 'NCT01119404', 'acronym': 'HMS-02', 'briefTitle': 'Hämeenlinna Metabolic Syndrome Research Program: Surrogate Indicators for Atherosclerosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kanta-Häme Central Hospital'}, 'officialTitle': 'Hämeenlinna Metabolic Syndrome Research Program (HMS): Surrogate Indicators for Atherosclerosis in Men With Metabolic Syndrome, Coronary Heart Disease and Controls', 'orgStudyIdInfo': {'id': 'KHMetS-02-AP'}, 'secondaryIdInfos': [{'id': 'HMS-02', 'type': 'OTHER', 'domain': 'Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Metabolic Syndrome', 'description': '120 men with metabolic syndrome'}, {'label': 'Coronary Heart Disease (CHD)', 'description': '120 men with angiographically verified CHD'}, {'label': 'Control', 'description': '80 physically active men'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13100', 'city': 'Hämeenlinna', 'status': 'COMPLETED', 'country': 'Finland', 'facility': 'Linnan Klinikka', 'geoPoint': {'lat': 60.99596, 'lon': 24.46434}}, {'zip': '13100', 'city': 'Hämeenlinna', 'status': 'COMPLETED', 'country': 'Finland', 'facility': 'Mehiläinen Hämeenlinna', 'geoPoint': {'lat': 60.99596, 'lon': 24.46434}}, {'zip': '13530', 'city': 'Hämeenlinna', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Ari K Palomäki, MD PhD', 'role': 'CONTACT', 'email': 'ari.palomaki@khshp.fi', 'phone': '+35836294540'}, {'name': 'Kalevi Oksanen, MD PhD', 'role': 'CONTACT', 'email': 'kalevi.oksanen@khshp.fi', 'phone': '+35836292369'}, {'name': 'Hanna P Pohjantähti-Maaroos, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sari Husgafvel, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Päivi Kankkunen, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ari K Palomäki, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kalevi Oksanen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Central Hospital of Kanta-Häme', 'geoPoint': {'lat': 60.99596, 'lon': 24.46434}}, {'zip': '00310', 'city': 'Helsinki', 'status': 'COMPLETED', 'country': 'Finland', 'facility': 'Finnish Red Cross Blood Transfusion Service', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'centralContacts': [{'name': 'Ari K Palomäki, MD PhD', 'role': 'CONTACT', 'email': 'ari.palomaki@khshp.fi', 'phone': '+35836294540'}, {'name': 'Kalevi Oksanen, MD PhD', 'role': 'CONTACT', 'email': 'kalevi.oksanen@khshp.fi', 'phone': '+35836292369'}], 'overallOfficials': [{'name': 'Ari K Palomäki, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Central Hospital of Kanta-Häme'}, {'name': 'Kalevi Oksanen, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Central Hospital of Kanta-Häme'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanta-Häme Central Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Linnan Klinikka Oy', 'class': 'OTHER'}, {'name': 'Mehiläinen Hämeenlinna, Finland', 'class': 'UNKNOWN'}, {'name': 'Finnish Red Cross Blood Service', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Ari Palomäki, MD PhD', 'oldOrganization': 'Central Hospital of Kanta-Häme'}}}}