Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-01-24 @ 5:25 AM
Study NCT ID:
NCT03653468
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2018-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise for Preventing the Metabolic Syndrome in Latinoamerican Amerindians
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Behavioral'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-29', 'studyFirstSubmitDate': '2018-08-28', 'studyFirstSubmitQcDate': '2018-08-29', 'lastUpdatePostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting glucose', 'timeFrame': 'Baseline and 20-weeks immediately after the interventions ends', 'description': 'Change from Baseline in fasting glucose'}, {'measure': 'Total cholesterol', 'timeFrame': 'Baseline and 20-weeks immediately after the interventions ends', 'description': 'Change from baseline in Total cholesterol'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline and 20-weeks immediately after the interventions ends', 'description': 'Change from baseline in Blood pressure'}], 'secondaryOutcomes': [{'measure': 'Body mass', 'timeFrame': 'Baseline and 20-weeks immediately after the interventions ends', 'description': 'Change from Baseline in body mass'}, {'measure': 'Waist circumference', 'timeFrame': 'Baseline and 20-weeks immediately after the interventions ends', 'description': 'Change from Baseline in waist circumference'}, {'measure': 'Fat mass', 'timeFrame': 'Baseline and 20-weeks immediately after the interventions ends', 'description': 'Change from Baseline in fat mass'}, {'measure': 'Lean mass', 'timeFrame': 'Baseline and 20-weeks immediately after the interventions ends', 'description': 'Change from Baseline in lean mass'}, {'measure': 'Heart rate at rest', 'timeFrame': 'Baseline and 20-weeks immediately after the interventions ends', 'description': 'Change from Baseline in heart rate at rest'}, {'measure': 'Six minutes walking test', 'timeFrame': 'Baseline and 20-weeks immediately after the interventions ends', 'description': 'Change from Baseline in six minutes walking test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Cardiovascular Risk Factor', 'Physical Activity']}, 'descriptionModule': {'briefSummary': "Despite exercise training decrease blood fasting glicaemy in 'average' terms, there is a wide inter-individual variability after exercise training explored mainly in adults but not in adults with prediabetes comorbidities. Thus, is yet unknown the effects and influence of the concurrent training (CT) eliciting responders (R) and non-responders (NR) cases (i.e., percentage of subjects who experienced a non-change/worsened response after training in some metabolic outcomes)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Interested in improving health and fitness\n\nExclusion Criteria:\n\n* Cardiovascular contraindications to exercise\n* History of stroke, asthma or chronic obstructive pulmonary disease, muscle-skeletal disorders\n* Smoking\n* A compliance rate to the exercise program ≥ 70% was required for the participants in the intervention group to be included in the statistical analyses.'}, 'identificationModule': {'nctId': 'NCT03653468', 'briefTitle': 'Exercise for Preventing the Metabolic Syndrome in Latinoamerican Amerindians', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Santo Tomas'}, 'officialTitle': 'Similar Improvements in Cardiometabolic Risk Factors for Preventing the Metabolic Syndrome in Latinoamerican Amerindians After 12-weeks of Concurrent Training', 'orgStudyIdInfo': {'id': '28082018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No-exercise'}, {'type': 'EXPERIMENTAL', 'label': 'Endurance training plus resistant training', 'description': 'Concurrent training', 'interventionNames': ['Behavioral: Concurrent training (CT)']}], 'interventions': [{'name': 'Concurrent training (CT)', 'type': 'BEHAVIORAL', 'description': 'The core part of each session included resistance training (RT) followed by aerobic training exercises (for 50 and 30 minutes, respectively) and was preceded and followed by a 5-minute warm-up and cool-down with callisthenic movements.', 'armGroupLabels': ['Endurance training plus resistant training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '000000000', 'city': 'Los Lagos', 'state': 'Osorno', 'country': 'Chile', 'facility': 'Cristian Alvarez', 'geoPoint': {'lat': -39.8635, 'lon': -72.80914}}], 'overallOfficials': [{'name': 'Cristian Alvarez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Los Lagos'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Statistical Analysis Plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Santo Tomas', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad del Rosario', 'class': 'OTHER'}, {'name': 'Universidad Pública de Navarra', 'class': 'OTHER'}, {'name': 'Healthcare Center Tomas Rojas', 'class': 'OTHER'}, {'name': 'Universidad de Los Lagos', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}