Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-31 @ 9:54 PM
Study NCT ID:
NCT00666094
Status:
COMPLETED
Last Update Posted:
2017-02-09
First Post:
2008-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Trial of Exercise Training Among Men With Type 2-diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], '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': 'D000076663', 'term': 'Endurance Training'}, {'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'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': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-07', 'studyFirstSubmitDate': '2008-04-23', 'studyFirstSubmitQcDate': '2008-04-23', 'lastUpdatePostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1C', 'timeFrame': '12.01.08'}], 'secondaryOutcomes': [{'measure': 'body composition, C-peptid, BP, Cholesterol (LDL, HDL), Triglycerides', 'timeFrame': '12.01.08'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2-diabetes', 'exercise therapy', 'RCT', 'Norway'], 'conditions': ['Diabetes Mellitus, Type 2', 'Hyperglycemia']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Moe B, Augestad LB, Åsvold BO, Flanders WD. Effects of aerobic versus resistance training on glycaemic control in men with type 2 diabetes. European Journal of Sports Science 11(5): 365-374, 2011'}]}, 'descriptionModule': {'briefSummary': 'To test the hypothesis that there is no difference in change in HbA1C among men with type 2-diabetes after an exercise intervention with strength versus endurance training.', 'detailedDescription': 'Exercise training is well documented as part of effective treatment for type 2-diabetes patients. Endurance training has been suggested as the most suitable form of exercise. There are reasons to believe that strength training also has a positive effect. However, comparisons of endurance training and strength training regimes are limited.\n\nTherefore we randomized 26 men with type 2-diabetes to either an endurance training group or a strength training group. Both groups exercised three sessions per week for three months. The training was supervised.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '71 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with type 2-diabetes\n* Male, 35-71 years\n* Managing their diabetes through a lifestyle and/or the drug metformin only\n* Able to participate in either of the exercise groups\n\nExclusion Criteria:\n\n* Symptomatic cardiovascular disease\n* Uncontrolled hypertension\n* Physical or cognitive disabilities that will interfere with participating in the exercise regimes.\n* Trained consistently during the last six months.'}, 'identificationModule': {'nctId': 'NCT00666094', 'briefTitle': 'A Randomized Controlled Trial of Exercise Training Among Men With Type 2-diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'A Randomized Controlled Trial of Strength Versus Aerobic Exercise Training to Improve Glycemic Control in Men With Type 2-diabetes', 'orgStudyIdInfo': {'id': '520073168'}, 'secondaryIdInfos': [{'id': '520073168', 'type': 'OTHER', 'domain': 'SVT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'endurance training', 'description': 'supervised endurance training', 'interventionNames': ['Behavioral: Endurance training']}, {'type': 'EXPERIMENTAL', 'label': 'strength training', 'description': 'Supervised strength training', 'interventionNames': ['Behavioral: strength training']}], 'interventions': [{'name': 'Endurance training', 'type': 'BEHAVIORAL', 'otherNames': ['Aerobic training'], 'description': 'supervised endurance training. Three sessions per week in three months.', 'armGroupLabels': ['endurance training']}, {'name': 'strength training', 'type': 'BEHAVIORAL', 'description': 'Supervised strength training. Three sessions per week in three months.', 'armGroupLabels': ['strength training']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'country': 'Norway', 'facility': 'NTNU', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Liv B Augestad, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Taiwan Normal University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}