Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2025-12-26 @ 5:35 PM
Study NCT ID:
NCT00365495
Status:
UNKNOWN
Last Update Posted:
2007-04-04
First Post:
2006-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Physical Training on Mitochondrial Function in Type 2 Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2007-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-04-03', 'studyFirstSubmitDate': '2006-08-15', 'studyFirstSubmitQcDate': '2006-08-15', 'lastUpdatePostDateStruct': {'date': '2007-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mitochondrial respiratory measurements. The investigations are carried out by two rounds - one before Christmas and one after.'}], 'secondaryOutcomes': [{'measure': 'VO2max'}, {'measure': 'Lipid oxidation'}, {'measure': 'muscle fiber type composition'}, {'measure': 'muscle oxidative enzymes'}, {'measure': 'mitochondrial-specific proteins (UCP3)'}, {'measure': 'mitochondrial production of free oxygen radicals'}]}, 'conditionsModule': {'keywords': ['Type 2 diabetes', 'physical training', 'mitochondrial function'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Physical activity as treatment for patients with type 2 diabetes (T2D). Treatment of T2D is often done by medication, changing the diet and increased physical activity. It is well established that physical training has a positive effect on the pathology of T2D such as increased insulin sensitivity and reduced fasting plasma glucose (7) and blood lipids (15). It is also well known that in healthy subjects endurance training increases mitochondrial density, lipid oxidation during submaximal exercise, and results in a number of qualitative changes in the control of OXPHOS (24). However, the effect of physical training on the mitochondrial function in skeletal muscle of patients with T2D has not been investigated.\n\nThe purpose of this project is to investigate the effect of physical training on the mitochondrial respiratory function in muscles of patients with T2D. Skeletal muscle biopsies will be taken before and after 10 weeks of physical training in patients with T2D and matched control subjects. Mitochondria will be isolated from the muscle biopsies, and respiratory function, free radical production and UCP3 will be determined. Furthermore, measures of maximal oxygen consumption (VO2max), heart rate and capillary lactate concentrations and carbohydrate and lipid oxidation will be determined partly to verify an increased aerobic capacity and partly to investigate the changes in these factors in T2D patients.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male,\n* BMI above 26,\n* Age between 40 and 65,\n* Living a sedentary lifestyle\n\nExclusion Criteria:\n\n* Women\n* BMI under 26\n* Age under 40 and over 65\n* Trained subjects Control subjects: relatives to type 2 diabetic patients, T2D trial subjects'}, 'identificationModule': {'nctId': 'NCT00365495', 'briefTitle': 'Influence of Physical Training on Mitochondrial Function in Type 2 Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'orgStudyIdInfo': {'id': '022'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Physical training (aerobic training)', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'University of Southern Denmark and Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Martin Mogensen, PhD student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}}}}