Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-31 @ 12:53 PM
Study NCT ID:
NCT01377558
Status:
UNKNOWN
Last Update Posted:
2011-06-23
First Post:
2011-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Different Types of Exercise Interventions in Patients 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': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004368', 'term': 'Dry Socket'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-22', 'studyFirstSubmitDate': '2011-06-09', 'studyFirstSubmitQcDate': '2011-06-20', 'lastUpdatePostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c-level (haemoglobin A1c)', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Change in HOMA-Index', 'timeFrame': '3 and 6 months'}, {'measure': 'Change in beta-cell-function', 'timeFrame': '3 and 6 months', 'description': 'Measured by OGTT (Oral Glucose Tolerance Test)'}, {'measure': 'Change in fasting plasma glucose levels', 'timeFrame': '3 and 6 months'}, {'measure': 'Change in total cholesterol levels', 'timeFrame': '3 and 6 months'}, {'measure': 'Change in HDL-cholesterol levels', 'timeFrame': '3 and 6 months'}, {'measure': 'Change in LDL-cholesterol levels', 'timeFrame': '3 and 6 months'}, {'measure': 'Change in triglyceride levels', 'timeFrame': '3 and 6 months'}, {'measure': 'Change in antidiabetic medications', 'timeFrame': '3 and 6 months', 'description': 'Class and dosage of blood-glucose lowering drugs are recorded before, after 3 and 6 months'}, {'measure': 'Change in inflammation markers', 'timeFrame': '3 and 6 months', 'description': 'CrP, blood count, interleukinstatus, cytokinstatus'}, {'measure': 'Change in body weight', 'timeFrame': '3 and 6 months'}, {'measure': 'Change in body composition', 'timeFrame': '3 and 6 months', 'description': 'by Bio-impedance analysis, waist to hip ratio, range of thigh'}, {'measure': 'Change in strength', 'timeFrame': '3 and 6 months', 'description': 'by Dr. Wolff Back Check'}, {'measure': 'Change of maximum heart rate', 'timeFrame': '3 and 6 months', 'description': 'Measured by an incremental exercise test'}, {'measure': 'Change of peak oxygen uptake', 'timeFrame': '3 and 6 months', 'description': 'Measured by an incremental exercise test'}, {'measure': 'Change of vAT (ventilatory anaerobic threshold)', 'timeFrame': '3 and 6 months', 'description': 'Measured by an incremental exercise test'}, {'measure': 'Change in blood pressure', 'timeFrame': '3 and 6 months'}, {'measure': 'Change in renal function', 'timeFrame': '3 and 6 months', 'description': 'Creatininlevel, Albuminlevel (urine), Telomere length'}, {'measure': 'Change in concentration', 'timeFrame': '3 and 6 months', 'description': 'by d2-test'}, {'measure': 'Change in quality of life', 'timeFrame': '3 and 6 months', 'description': 'by questionnaire: SF-12, EQ5'}, {'measure': 'Change of nutrition', 'timeFrame': '3 and 6 months', 'description': 'by questionnaire: FEV, FFQ'}, {'measure': 'Change in voluntary physical activity', 'timeFrame': '3 and 6 months', 'description': 'meassured by pedometer (one week)'}, {'measure': 'Change of cardiac output by Impedance cardiography', 'timeFrame': '3 and 6 months', 'description': 'by Task Force Monitor'}, {'measure': 'Change of barorezeptorsensitivity', 'timeFrame': '3 and 6 months', 'description': 'by Task Force Monitor'}, {'measure': 'Change in carotid-Intima-Media-Thickness', 'timeFrame': '3 and 6 months'}, {'measure': 'Change in aortic pulse-wave velocity', 'timeFrame': '3 and 6 months'}, {'measure': 'Change in central aortic pressure', 'timeFrame': '3 and 6 month'}, {'measure': 'Change in endothelial dysfunction', 'timeFrame': '3 and 6 months'}, {'measure': 'Change of parodontitis', 'timeFrame': '3 and 6 months'}, {'measure': 'Follow up of all parameters mentioned above', 'timeFrame': 'after 12 months', 'description': 'Follow up after 12 months (6 months after completing the exercise intervention) without any supervised intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['aerobic training', 'resistance training', 'combination of aerobic and resistance training', 'diabetes', 'type 2 diabetes', 'HbA1c', 'endothelial dysfunction', 'inflammation markers', 'Parodontitis', 'Exercise intervention', 'training'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purposes of the study are\n\n* to determine which kind of supervised exercise intervention (aerobic endurance training versus strength endurance training versus combined aerobic endurance and strength endurance training) is more effective in improving the metabolic parameters in typ 2 diabetes patients\n* to investigate what kind of intervention is more successful in reduction of concomitant diseases and improving quality of life\n* to assess what kind of intervention induces highest effects in long term persistence of these positive changes', 'detailedDescription': 'Meta-analyses which evaluated the effects of structured exercise programs in patients with type 2 diabetes demonstrate that regular physical activity improves glycosylated haemoglobin (König et al.: Resistance Exercise and Type 2 Diabetes Mellitus, Deutsche Zeitschrift für Sportmedizin Jahrgang 62, Nr. 1 (2011): 5-9). Sigal et al. proved that either aerobic or resistance training alone improved glycemic control in type 2 diabetes, but the improvements are greatest with combined aerobic and resistance training (Sigal, RJ, et al.: Effects of Aerobic Training, Resistance Training, or Both on Glycemic Control in Type 2 Diabetes, Ann Intern Med. 2007 Sep 18;147(6):357-69).\n\nTherefore, aim of the current study is to compare the effects of aerobic endurance training or resistance endurance training or the combination of aerobic endurance training and resistance endurance training in diabetes type 2 patients without any other lifestyle or dietary interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnoses of type 2 diabetes (ADA criteria)\n* admitted diabetes treatments will be diet and oral hypoglycemic agents\n\nExclusion Criteria:\n\n* sports intervention \\>60 minutes per week\n* medical conditions\n* preproliferative or proliferative retinopathy\n* instable coronary heart disease\n* inability to perform the scheduled physical activity programs\n* acute clinically significant intercurrent diseases'}, 'identificationModule': {'nctId': 'NCT01377558', 'briefTitle': 'Effects of Different Types of Exercise Interventions in Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Giessen'}, 'officialTitle': 'Effects of Different Types of Exercise Interventions in Patients With Type 2 Diabetes - Aerobic Endurance Training Versus Strength Endurance Training Versus Combined Aerobic Endurance and Strength Endurance Training -', 'orgStudyIdInfo': {'id': 'Gi-03-2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aerobic endurance training intervention', 'description': 'Aerobic endurance training', 'interventionNames': ['Other: Aerobic endurance training intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Strength endurance training intervention', 'description': 'Strength endurance training', 'interventionNames': ['Other: Strength endurance training intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Combined training intervention', 'description': 'Combined aerobic endurance training and strength endurance training intervention', 'interventionNames': ['Other: Combined aerobic endurance and strength endurance training']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'control group'}], 'interventions': [{'name': 'Aerobic endurance training intervention', 'type': 'OTHER', 'otherNames': ['aerobic endurance training'], 'description': 'The aerobic endurance training group will use cardiovascular training devices\n\nweek 1-4: 15 minutes warm up (group) 15 minutes intervention at 80-100% vAT two times per week\n\nweek 5-13: 15 minutes warm up (group) 30 minutes intervention at 95-110% vAT two times per week\n\nweek 14-26: 15 minutes warm up (group) 45 minutes intervention at 95-110% vAT two times per week', 'armGroupLabels': ['Aerobic endurance training intervention']}, {'name': 'Strength endurance training intervention', 'type': 'OTHER', 'otherNames': ['Strength endurance training'], 'description': 'The strength endurance training intervention group will perform eight exercises on weight machines (Milon circuit training- 60 seconds activity, 30 seconds break)\n\nweek 1-4: 15 minutes warm up (group) 1 session resistance training intensity 3 (Buskies) two times per week\n\nweek 5-13: 15 minutes warm up (group) 2 sessions resistance training intensity 5 (Buskies) two times per week\n\nweek 14-26: 15 minutes warm up (group) 3 sessions resistance training intensity 5 (Buskies) two times per week', 'armGroupLabels': ['Strength endurance training intervention']}, {'name': 'Combined aerobic endurance and strength endurance training', 'type': 'OTHER', 'description': 'week 1-4: 15 minutes warm up (group) 15 minutes intervention at 80-100% vAT once per week and 15 minutes warm up (group) 1 session resistance training intensity 3 (Buskies) once per week\n\nweek 5-13: 15 minutes warm up (group) 15 minutes intervention at 95-110% vAT and 1 session resistance training intensity 5 (Buskies) two times per week\n\nweek 14-26: 15 minutes warm up (group) 30 minutes intervention at 95-110% vAT and 1 session resistance training intensity 5 (Buskies) once a week and 15 minutes warm up (group) 15 minutes intervention at 95-110% vAT and 2 sessions resistance training intensity 5 (Buskies) once a week', 'armGroupLabels': ['Combined training intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35394', 'city': 'Giessen', 'state': 'Hesse', 'country': 'Germany', 'facility': 'University of Giessen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '08056', 'city': 'Zwickau', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Sportpark Zwickau, Glauchau, Meerane', 'geoPoint': {'lat': 50.72724, 'lon': 12.48839}}], 'overallOfficials': [{'name': 'Andree Hillebrecht, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Giessen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Giessen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hannover Medical School', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Andree Hillebrecht, Dr. med.', 'oldOrganization': 'Department of Sports Medicine Giessen'}}}}