Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2026-01-02 @ 1:46 AM
Study NCT ID:
NCT00946868
Status:
COMPLETED
Last Update Posted:
2009-07-27
First Post:
2009-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Metabolic Syndrome in Patients With Intermittent Claudication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007383', 'term': 'Intermittent Claudication'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-23', 'studyFirstSubmitDate': '2009-07-23', 'studyFirstSubmitQcDate': '2009-07-23', 'lastUpdatePostDateStruct': {'date': '2009-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of metabolic syndrome in patients with intermittent claudication', 'timeFrame': 'After laboratory exams results.'}], 'secondaryOutcomes': [{'measure': 'Correlation of metabolic syndrome with age, sex, localization of the arterial obstruction and the association with symptomatic coronary artery disease.', 'timeFrame': 'At the end of data collection'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intermittent claudication', 'metabolic syndrome'], 'conditions': ['Intermittent Claudication', 'Metabolic Syndrome X']}, 'referencesModule': {'references': [{'pmid': '16520719', 'type': 'RESULT', 'citation': 'Ambrosetti M, Salerno M, Laporta A, Pedretti RF. Metabolic syndrome in patients with intermittent claudication referred to vascular rehabilitation. Int Angiol. 2006 Mar;25(1):14-7.'}, {'pmid': '15451914', 'type': 'RESULT', 'citation': 'Ford ES, Giles WH, Mokdad AH. Increasing prevalence of the metabolic syndrome among u.s. Adults. Diabetes Care. 2004 Oct;27(10):2444-9. doi: 10.2337/diacare.27.10.2444.'}, {'pmid': '12610004', 'type': 'RESULT', 'citation': 'Ford ES, Giles WH. A comparison of the prevalence of the metabolic syndrome using two proposed definitions. Diabetes Care. 2003 Mar;26(3):575-81. doi: 10.2337/diacare.26.3.575.'}, {'pmid': '11790215', 'type': 'RESULT', 'citation': 'Ford ES, Giles WH, Dietz WH. Prevalence of the metabolic syndrome among US adults: findings from the third National Health and Nutrition Examination Survey. JAMA. 2002 Jan 16;287(3):356-9. doi: 10.1001/jama.287.3.356.'}, {'pmid': '11368702', 'type': 'RESULT', 'citation': 'Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001 May 16;285(19):2486-97. doi: 10.1001/jama.285.19.2486. No abstract available.'}, {'pmid': '12485966', 'type': 'RESULT', 'citation': 'National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002 Dec 17;106(25):3143-421. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Metabolic syndrome, a group of cardiovascular risk factors related to insulin resistance, is a major determinant of cardiovascular mortality.\n\nIntermittent claudication is a symptom of an early stage of atherosclerosis.\n\nThe aim of this study is to determine the prevalence of the metabolic syndrome in patients with intermittent claudication and its correlation with age, gender, localization of arterial obstruction and association with coronary artery disease.', 'detailedDescription': 'Studies correlating metabolic syndrome and several illnesses are being published, especially affections associated with atherosclerosis, like coronary artery disease, cerebrovascular disease and peripheral arterial disease.\n\nThe term peripheral arterial disease, however, refers to several stages of the development of atherosclerosis in the extremities, comprising since asymptomatic patients as far as individuals with critical ischemia.\n\nIntermittent claudication is a symptom of an early stage of atherosclerosis, when medical interventions may still prevent the progression of the disease. Despite the importance of a precocious diagnosis of metabolic syndrome to initiate adequate treatment, its prevalence among these patients is not well determined in the literature.\n\nThis is the biggest casuistic in the literature as far as we know.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients of the Vascular and Endovascular Department (Intermittent Claudicantion Group)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients with complaints compatible with intermittent claudication of the lower limbs, absence or weakness of arterial pulses on the limb or limbs that are limiting deambulation, ankle-brachial index simila or lower than 0.9\n\nExclusion Criteria:\n\n* patients with critical limb ischaemia'}, 'identificationModule': {'nctId': 'NCT00946868', 'briefTitle': 'Prevalence of Metabolic Syndrome in Patients With Intermittent Claudication', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Prevalence of Metabolic Syndrome in Patients With Intermittent Claudication', 'orgStudyIdInfo': {'id': '0143/09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intermittent claudication patients', 'description': 'Patients with intermittent claudication with metabolic syndrome and patients with intermittent claudication without metabolic syndrome.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403 000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Nelson Wolosker, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}, {'name': 'Pedro P Leao, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Nelson Wolosker, PhD', 'oldOrganization': 'University of Sao Paulo'}}}}