Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT01090869
Status:
COMPLETED
Last Update Posted:
2010-03-23
First Post:
2010-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physical Training Per se
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-22', 'studyFirstSubmitDate': '2010-03-16', 'studyFirstSubmitQcDate': '2010-03-22', 'lastUpdatePostDateStruct': {'date': '2010-03-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in insulin sensitivity', 'timeFrame': 'week 0 and 13', 'description': 'Before and after the 12 week interventions a 1-step, 120 min, hyperinsulinaemic, euglycemic clamp was performed. After an initial 2mL bolus of insulin infusate, insulin was infused at 40 microU/min/kg.'}], 'secondaryOutcomes': [{'measure': 'Changes in body composition', 'timeFrame': 'DEXA: week 0, 2, 6, 10, and 13; MRI: Week 0 and 13', 'description': 'Before, during and after the 12-week interventions changes in: Body mass, Lean body mass, Fat mass, Abdominal fat mass, and Viceral and subcutaneous fat were assesed by DEXA and MRI scans.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Insulin Sensitivity']}, 'descriptionModule': {'briefSummary': 'The investigators aimed to evaluate the health benefits of physical training per se, weight loss per se and exercise-induced weight loss in young, overweight men. The investigators hypothesized that physical training would have independent effects on various health parameters (insulin sensitivity, fasting glucose and insulin, total and abdominal fat mass, waist circumference, blood pressure and key muscle proteins), and that a concomitant weight loss from physical activity would increase the effect.', 'detailedDescription': 'At baseline, during the intervention and in the week following the intervention participants underwent a panel of tests:\n\n* Cardio respiratory fitness\n* blood pressure\n* anthropometric measures\n\nAt baseline and after the intervention a hyperinsulinemic, euglycemic clamp were performed to asses insulin sensitivity.\n\nTissue and blood samples were also collected for further analysis:\n\n* Total-protein analysis of selected proteins\n* Fasting plasma glucose, insulin and free fatty acids'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overweight (body mass index 25-30 kg/m2)\n* Weight stable (±2 kg during the past 6 months)\n* Body fat% \\>25%,\n* Maximal oxygen uptake \\<45 mL/min/kg\n* Sedentary and healthy according to interview\n* Fasting glucose \\<6.1 mmol/L\n* Blood pressure \\<140/90 mmHg\n* No first degree relatives with type-2-diabetes\n\nExclusion Criteria:\n\n* Resistance training\n* Inability to meet intervention criteria'}, 'identificationModule': {'nctId': 'NCT01090869', 'acronym': 'TPS', 'briefTitle': 'Physical Training Per se', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Physical Activity is Healthy - Effect of Weight Loss or Physical Training Per se?', 'orgStudyIdInfo': {'id': 'H-KF-2006-6443'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Physical training, unchanged diet', 'description': 'Daily endurance training equivalent to 600 kcal/day and unchanged habitual diet', 'interventionNames': ['Behavioral: 12 weeks of lifestyle change']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Physical training, increased diet', 'description': 'Daily endurance training equivalent to 600 kcal/day, and increased diet by 600 kcal/day.', 'interventionNames': ['Behavioral: 12 weeks of lifestyle change']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diet, unchanged physical activity', 'description': 'Energy-reduced diet by 600 kcal/day, and unchanged sedentary lifestyle', 'interventionNames': ['Behavioral: 12 weeks of lifestyle change']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Unchanged sedentary lifestyle and diet', 'interventionNames': ['Behavioral: 12 weeks of lifestyle change']}], 'interventions': [{'name': '12 weeks of lifestyle change', 'type': 'BEHAVIORAL', 'description': 'Participants were randomly assigned to a 12-week intervention in one of four groups: Training (T), energy-reduced Diet (D), Training and increased- Diet (T-iD) or Control (C). The interventions consisted of: T: increased physical activity through daily endurance training equivalent to 600 kcal/day, unchanged diet; D: sedentary lifestyle, reduced diet by 600 kcal/day primarily through reducing serving sizes and substituting energy dense with less energy dense nutrients; T-iD: increased physical activity through daily endurance training equivalent to 600 kcal/day, increased diet by 600 kcal/day primarily through increasing serving sizes and consuming energy dense nutrients; C: sedentary lifestyle and unchanged diet.', 'armGroupLabels': ['Control', 'Diet, unchanged physical activity', 'Physical training, increased diet', 'Physical training, unchanged diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2200', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'University of Copenhagen, Faculty Of Health Sciences, Department of Biomedical Sciences', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Pernille Nordby, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ph.D., D.Ms. Bente M. Stallknecht', 'oldOrganization': 'University of Copenhagen'}}}}