Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-25 @ 4:25 AM
Study NCT ID:
NCT03502304
Status:
COMPLETED
Last Update Posted:
2018-05-31
First Post:
2018-04-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concurrent Training and Prediabetes Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D009765', 'term': 'Obesity'}], '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': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000076663', 'term': 'Endurance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-16', 'size': 174209, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-04-17T12:08', 'hasProtocol': True}]}}, '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': '2017-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-29', 'studyFirstSubmitDate': '2018-04-09', 'studyFirstSubmitQcDate': '2018-04-17', 'lastUpdatePostDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-09', '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': 'Lipoproteins', 'timeFrame': 'Baseline and 20-weeks immediately after the interventions ends', 'description': 'Change from baseline in lipoproteins'}], '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': {'keywords': ['Metabolic syndrome', 'Obesity'], 'conditions': ['Metabolic Disturbance']}, '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,\n* Muscle-skeletal disorders, and\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': 'NCT03502304', 'briefTitle': 'Concurrent Training and Prediabetes Control', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Santo Tomas'}, 'officialTitle': 'Concurrent Training and Prediabetes Comorbidities: An Analysis of Non-responders Using Clinical Cutoff Points', 'orgStudyIdInfo': {'id': '9042018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'No-exercise', 'interventionNames': ['Behavioral: Endurance training plus resistant training']}, {'type': 'EXPERIMENTAL', 'label': 'Endurance training plus resistant training', 'description': 'To concurrent training (endurance training plus resistant training, RT) program will be use cycle ergometers adapted for obese adults (OXFORDTM, model BE2601, OXOFORD Inc, Santiago, Chile) were used. Prior to the CT intervention, all subjects were familiarized (during 3 sessions) with the training protocols. The CT intervention included 3 weekly sessions of both ET and RT. The core part of each session included RT followed by ET exercises (for 50 and 30 minutes, respectively) and was preceded and followed by a 5-minute warm-up and cool-down with callisthenic movements.', 'interventionNames': ['Behavioral: Endurance training plus resistant training']}], 'interventions': [{'name': 'Endurance training plus resistant training', 'type': 'BEHAVIORAL', 'description': 'CT in women with prediabetes and co-morbidities associated. Exercise will be performed at three sessions per week. Post statistical analyses will be including analyses by the 2 groups proposed. All sessions will be supervised by an exercise physiologist during 20-weeks.', 'armGroupLabels': ['Control group', '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'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Santo Tomas', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad de Los Lagos', 'class': 'OTHER'}, {'name': 'Healthcare Center Tomas Rojas', 'class': 'OTHER'}, {'name': 'Universidad del Rosario', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}