Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-03 @ 9:51 PM
Study NCT ID:
NCT03036332
Status:
COMPLETED
Last Update Posted:
2017-01-30
First Post:
2017-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Training and Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-27', 'studyFirstSubmitDate': '2017-01-26', 'studyFirstSubmitQcDate': '2017-01-27', 'lastUpdatePostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pro-inflammatory marker', 'timeFrame': '16 weeks', 'description': 'Serum levels of C-reactive protein'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '16 weeks', 'description': 'The Medical Outcomes Study-Short Form 36 (SF-36)'}, {'measure': 'A set of clinical biomarkers', 'timeFrame': '16 weeks', 'description': 'Serum levels lof Homocysteine; Creatinine, Creatine kinase (ck); creatine kinase MB (ck-mb); Troponin t; aspartate aminotransferase; alanine aminotransferase; and complete blood count.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aerobic interval training', 'biomarkers'], 'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'The present study aimed to determine the effects of 16 weeks of aerobic interval training on quality of life and a set of clinical biomarkers.', 'detailedDescription': 'Besides the traditional metabolic syndrome risk factors (dyslipidemia, raised blood pressure, central obesity and dysglycemia) subclinical disorders related to chronic inflammation and cell damage have been reported on metabolic syndrome. Therefore, regarding the systemic feature of metabolic syndrome, we investigated an new approach of aerobic interval training on several clinical biomarkers widely used. Such training used differs from current aerobic protocols in order to attenuate metabolic and musculoskeletal overload on untrained and unhealthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having metabolic syndrome according to international diabetes foundations definition (IDF).\n* Age between 35 - 60 years and untrained subjects.\n\nExclusion Criteria:\n\n* Musculotendinous or osteoarticular injuries in the lower limbs and/or spine\n* Chronic pulmonary diseases\n* Neurological disorders\n* Kidney failure\n* High-risk cardiovascular diseases (Unstable angina pectoris, Uncompensated heart failure, complex ventricular arrhythmias or myocardial infarction during the last month).'}, 'identificationModule': {'nctId': 'NCT03036332', 'briefTitle': 'Exercise Training and Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Estadual Paulista Júlio de Mesquita Filho'}, 'officialTitle': 'Effects of Aerobic Interval Training on Clinical Biomarkers and Quality of Life in Metabolic Syndrome', 'orgStudyIdInfo': {'id': 'RATMiranda1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'Aerobic interval training', 'interventionNames': ['Behavioral: Aerobic interval training']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The participants performed only initial evaluation and at the end of the study'}], 'interventions': [{'name': 'Aerobic interval training', 'type': 'BEHAVIORAL', 'description': 'Carried out 3 times per week for 16 weeks', 'armGroupLabels': ['intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rodolfo AT Miranda, Me', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Estadual Paulista Júlio de Mesquita'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Estadual Paulista Júlio de Mesquita Filho', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mr. Rodolfo Augusto Travagin Miranda', 'investigatorFullName': 'Rodolfo Augusto Travagin Miranda', 'investigatorAffiliation': 'Universidade Estadual Paulista Júlio de Mesquita Filho'}}}}