Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 5:05 AM
Study NCT ID:
NCT00638560
Status:
COMPLETED
Last Update Posted:
2010-01-20
First Post:
2008-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes of Biomarkers in Response to Training and Antioxidant Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'C563733', 'term': 'Carotid Intimal Medial Thickness 1'}], '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': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}, {'id': 'D014810', 'term': 'Vitamin E'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-19', 'studyFirstSubmitDate': '2008-03-12', 'studyFirstSubmitQcDate': '2008-03-12', 'lastUpdatePostDateStruct': {'date': '2010-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PGC-1alpha mRNA expression in skeletal muscle PPARgamma mRNA expression in skeletal muscle Serum malondialdehyde concentration', 'timeFrame': 'after 4 weeks'}], 'secondaryOutcomes': [{'measure': 'body weight glucose infusion rate during the steady state of an euglycemic-hyperinsulinemic clamp VO2max', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PGC-1alpha', 'PPARgamma', 'oxidative stress', 'training intervention'], 'conditions': ['Obesity', 'Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '19433800', 'type': 'DERIVED', 'citation': 'Ristow M, Zarse K, Oberbach A, Kloting N, Birringer M, Kiehntopf M, Stumvoll M, Kahn CR, Bluher M. Antioxidants prevent health-promoting effects of physical exercise in humans. Proc Natl Acad Sci U S A. 2009 May 26;106(21):8665-70. doi: 10.1073/pnas.0903485106. Epub 2009 May 11.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the effects of an intensive 4 weeks exercise training program with or without additional treatment with antioxidants. 16 volunteers are included into the study and randomized into a treatment (n=8,Vitamine E 400 IU od + vitamine C 1g twice daily) and a non-treatment (n=8, training only) group. Before and after the training program, skeletal muscle biopsies will be taken to measure PGC-1alpha and PPARgamma mRNA expression. In addition before and after the training program individuals will have the following measurements: body weight, waist circumference, body fat content (DEXA scan), euglycemic-hyperinsulinemic clamps, ergospirometer (VO2 max), routine laboratory measurements, serum malondialdehyde concentrations.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be able to swallow tablets\n* signed informed consent\n* no concommitant medication\n* male\n* age between 25 - 35 years\n\nExclusion Criteria:\n\n* drug, tobacco or alcohol abuse\n* any chronic disease\n* any acute or chronic inflammatory disease as determined by a leucocyte count \\> 7000 Gpt/l, C-reactive protein (CrP) \\> 5.0 mg/dl or clinical signs of infection\n* systolic blood pressure (SBP) \\> 140mmHg and diastolic blood pressure (DBP) was \\> 85mmHg\n* cardiovascular or peripheral artery disease\n* thyroid dysfunction'}, 'identificationModule': {'nctId': 'NCT00638560', 'briefTitle': 'Changes of Biomarkers in Response to Training and Antioxidant Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'officialTitle': 'Effects of Training and Antioxidant Treatment on Circulating Markers of Oxidative Stress and Skeletal Muscle mRNA Expression', 'orgStudyIdInfo': {'id': 'MB-MR-2008-290208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Antioxidant treatment arm:\n\nVitamin E, 400 IU po, once daily Vitamin C, 1g po, twice daily', 'interventionNames': ['Dietary Supplement: Vitamin C, Vitamin E']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Control', 'interventionNames': ['Dietary Supplement: Antioxidant treatment']}], 'interventions': [{'name': 'Vitamin C, Vitamin E', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Vitamin C, 1g po, twice daily Vitamin E, 400 IU po, once daily', 'armGroupLabels': ['1']}, {'name': 'Antioxidant treatment', 'type': 'DIETARY_SUPPLEMENT', 'description': 'no treatment', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'University of Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Matthias Blüher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Leipzig'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leipzig', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Jena', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Prof. Dr. med. Matthias Blüher', 'oldOrganization': 'Medical Department, University of Leipzig'}}}}