Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2025-12-29 @ 2:22 AM
Study NCT ID:
NCT01095068
Status:
TERMINATED
Last Update Posted:
2017-10-05
First Post:
2010-03-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Physical Exercise in Type 2 Diabetics
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'}]}, '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-04', 'studyFirstSubmitDate': '2010-03-25', 'studyFirstSubmitQcDate': '2010-03-26', 'lastUpdatePostDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the improvement in skeletal muscle energetic capacity, endothelial dysfunction and glycemic control induced by physical training in 20 sedentary patients with a type 2 diabetes.The protocol consists in a physical training program with 3 sessions of 30 minutes per week during six consecutive weeks. A skeletal muscle biopsy, a cardiac and humeral artery ultrasounds, a glycemic and tensional holters will be performed before and at the end of the physical training program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sedentary adult with type 2 diabetes\n* BMI between 25 and 35 kg/m²\n* Hba1c \\< 10 %\n\nExclusion Criteria:\n\n* unstable coronary artery disease\n* advanced peripheral occlusive arterial disease\n* proteinuria \\> 3 g/d and / or creatinine clearance \\< 30 ml / mn\n* advanced diabetic neuropathy'}, 'identificationModule': {'nctId': 'NCT01095068', 'briefTitle': 'Effects of Physical Exercise in Type 2 Diabetics', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Beneficial Effects of Exercise Training on Physical Capacity in Type 2 Diabetics: Improvement in Skeletal Muscle Energetic Capacity, Endothelial Dysfunction and Glycemic Control', 'orgStudyIdInfo': {'id': '3661'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'physical exercise', 'description': 'Physical exercise', 'interventionNames': ['Behavioral: Physical exercise']}], 'interventions': [{'name': 'Physical exercise', 'type': 'BEHAVIORAL', 'armGroupLabels': ['physical exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Médecine Interne et Nutrition, Hôpital Civil, Hôpitaux universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': "Service de Physiologie et d'Explorations Fonctionnelles, Nouvel Hôpital Civil, Hôpitaux universitaires de Strasbourg", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service de Médecine Interne et Nutrition, Hôpital de Hautepierre, Hôpitaux universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Alain PRADIGNAC, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpitaux Universitaires de Strasbourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}