Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-27 @ 7:33 PM
Study NCT ID:
NCT01435057
Status:
UNKNOWN
Last Update Posted:
2015-05-28
First Post:
2011-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Different Exercise Training Regimens on Visceral Fat Dynamic and Resting Energy Expenditure in Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056128', 'term': 'Obesity, Abdominal'}, {'id': 'C564245', 'term': 'Platelet Glycoprotein IV Deficiency'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-27', 'studyFirstSubmitDate': '2011-05-11', 'studyFirstSubmitQcDate': '2011-09-14', 'lastUpdatePostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MRI', 'timeFrame': 'Baseline and after 12 months after randomisation', 'description': 'Change from Baseline in abdominal visceral fat area as determined by MRI scans at the level of L4-L5 after 12 months of training intervention'}], 'secondaryOutcomes': [{'measure': 'MRI', 'timeFrame': 'Baseline, 12 and 24 months after randomisation', 'description': 'Changes from Baseline in abdominal visceral and subcutaneous fat area'}, {'measure': 'BIA', 'timeFrame': 'Baseline, 6, 12, 18 and 24 months after randomisation', 'description': 'Changes from Baseline in total body fat mass'}, {'measure': 'compliance to the intervention', 'timeFrame': 'over 24 months of intervention', 'description': 'compliance to the intervention of training (strength or endurance) as measured by the number of realized training units. Non-compliance = cumulative time bigger than six weeks per year'}, {'measure': 'well being as measured by SF-36', 'timeFrame': 'Baseline and every 6 months during intervention', 'description': 'Changes from Baseline in individual well being as measured by SF-36'}, {'measure': 'indirect calorimetry', 'timeFrame': 'Baseline, 6, 12, 18 and 24 months after randomisation', 'description': 'Changes from Baseline in resting energy expenditure'}, {'measure': 'fasting plasma glucose', 'timeFrame': 'Baseline and every 12 months', 'description': 'Changes from Baseline in fasting plasma glucose, insulin sensitivity and insulin secretion determined in oral glucose tolerance tests'}, {'measure': 'inflammatory parameters', 'timeFrame': 'Baseline and every 3 months during intervention', 'description': 'Changes from Baseline in inflammatory parameters'}, {'measure': 'adipokine serum concentrations', 'timeFrame': 'Baseline and every 3 months during intervention', 'description': 'Changes from Baseline in adipokine serum concentrations'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Abdominal Obesity', 'training', 'fat', 'insulin', 'glucose', 'diet'], 'conditions': ['Abdominal Obesity']}, 'descriptionModule': {'briefSummary': 'In this project, the investigators will test the hypothesis that predominant (two to three times a week 60 min) strength training is more effective in reducing visceral fat mass than endurance training in obese patients.', 'detailedDescription': 'Strength training (ST) was shown to be more effective than endurance training (ET) in improving glycemic control in the treatment of type 2 diabetes. However, it is unknown, whether different training strategies have different effects on the preferential visceral adipose tissue reduction and changes in resting energy expenditure in a population with abdominal obesity. We will therefore compare ST and ET (two to three times a week, 60 minutes per training session) in addition to a restricted energy intake of 1500kcal per day for women and 1800kcal per day for men in a prospective study of 200 individuals with abdominal obesity defined by a waist circumference \\> 102 cm for males and \\> 88 cm for females and a BMI \\> 35 kg/m² with regard to:\n\n1. Abdominal visceral adipose tissue area dynamic (MRI studies)\n2. Abdominal subcutaneous adipose tissue area dynamic (MRI studies)\n3. Total body fat mass changes (bioelectrical impedance analysis)\n4. Changes in resting energy expenditure (indirect calorimetry)\n5. Changes in parameters of glucose metabolism, insulin sensitivity and lipid profile\n6. Changes in circulating adipokines and markers of inflammation In addition, we will search for novel serum parameters, which predict the individual training response by a serum metabolomics/ proteomics approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\>= 35 kg/m2\n* waist circumference \\>102cm (men), \\>88cm (women)\n* age 18 - 60 years\n* written informed consent\n\nExclusion Criteria:\n\n* type 1 or type 2 diabetes\n* fasting plasma glucose \\>= 6.0 mmol/l\n* 2h-OGTT (oral glucose tolerance test) glucose \\>= 11.1 mmol/l\n* any chronic inflammatory or malignant disease\n* medical treatment which influences glucose metabolism\n* drug or alcohol abuse\n* psychiatric disorders\n* untreated thyroid dysfunction\n* cardiac pacemaker or other contraindication for MRI\n* attendant therapy with oral antidiabetic medication, GLP-1 mimetics or analoga, Insulin, anti-obesity medication (orlistat, sibutramine), Falithrom, antipsychotic drugs, any chemotherapeutics\n* pregnant or nursing women\n* expected low compliance\n* current participation in another investigational trial\n* last exercise training \\<= 6 months ago'}, 'identificationModule': {'nctId': 'NCT01435057', 'briefTitle': 'Effects of Different Exercise Training Regimens on Visceral Fat Dynamic and Resting Energy Expenditure in Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'officialTitle': 'Monocentric, Randomized, Controlled Study for Reduction on Visceral Fat Dynamic and Resting Energy Expenditure in Obese Patients Via Strength Versus Endurance Training (STEN Study - STrength Versus ENdurance Training)', 'orgStudyIdInfo': {'id': 'STEN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'endurance training', 'description': 'Endurance training:\n\nSupervised, twice a week, each training session consists of a 20 min warm up and cool down period and a minimum of 40min tread mill, rawing device or bicycle training.\n\nDuring the study period of 24 months, we will perform an open randomized, prospective training intervention study comparing the effects of three times a week either strength or endurance training on reduction of visceral fat area as determined by MRI scans at the level of L4-L5.', 'interventionNames': ['Procedure: exercise training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'strength training', 'description': 'Strength training:\n\nSupervised, twice a week, each training session consists of a 20 min warm up and cool down period and a minimum of 40min circle training\n\nDuring the study period of 24 months, we will perform an open randomized, prospective training intervention study comparing the effects of two to three times a week either strength or endurance training on reduction of visceral fat area as determined by MRI scans at the level of L4-L5.', 'interventionNames': ['Procedure: exercise training']}], 'interventions': [{'name': 'exercise training', 'type': 'PROCEDURE', 'description': 'comparison of strength versus endurance training (two or three times a week, 60 minutes per training session) over 24 months', 'armGroupLabels': ['endurance training', 'strength training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04103', 'city': 'Leipzig', 'state': 'Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Matthias Blüher, prof., MD', 'role': 'CONTACT', 'email': 'bluma@medizin.uni-leipzig.de', 'phone': '+493419715984'}, {'name': 'Nicole Bauernfeind', 'role': 'CONTACT', 'email': 'nicole.bauernfeind@zks.uni-leipzig.de', 'phone': '+493419716266'}, {'name': 'Matthias Blüher, prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Leipzig, Department of Medicine', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'centralContacts': [{'name': 'Matthias Blüher, prof., MD', 'role': 'CONTACT', 'email': 'bluma@medizin.uni-leipzig.de', 'phone': '+493419715984'}, {'name': 'Nicole Bauernfeind', 'role': 'CONTACT', 'email': 'nicole.bauernfeind@zks.uni-leipzig.de', 'phone': '+493419716266'}], 'overallOfficials': [{'name': 'Matthias Blüher, prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Leipzig'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leipzig', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'medical doctor', 'investigatorFullName': 'Matthias Bluher', 'investigatorAffiliation': 'University of Leipzig'}}}}