Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-28 @ 4:56 PM
Study NCT ID:
NCT01145092
Status:
COMPLETED
Last Update Posted:
2010-06-16
First Post:
2010-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Six Months of Moderate Resistance- Versus Endurance-Training on Muscle ATP Synthesis in First-Degree Relatives of 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': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D000076663', 'term': 'Endurance Training'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-15', 'studyFirstSubmitDate': '2010-06-14', 'studyFirstSubmitQcDate': '2010-06-15', 'lastUpdatePostDateStruct': {'date': '2010-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin Sensitivity', 'description': 'measured by oral glucose tolerance test'}], 'secondaryOutcomes': [{'measure': 'incremental test power, oxygen uptake (VO2 in ml.kg-1.min-1), "aerobic threshold" (RCP= respiratory compensation point)', 'description': 'This test was performed on an electronically braked cycle ergometer'}, {'measure': 'ATP-Synthesis', 'description': 'measured with 13C NMR'}, {'measure': 'liver lipid content', 'description': 'measured with 1H NMR'}, {'measure': 'skeletal muscle lipid content', 'description': 'measured by 1H NMR'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['type 2 diabetes', 'exercise training', 'ATP-synthesis', 'intramyocellular lipids', 'hepatocellular lipids', 'first degree relatives of T2DM patients'], 'conditions': ['Type 2 Diabetes Mellitus', 'Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'Life style intervention including diet and exercise is the recommended strategy for prevention of type 2 diabetes mellitus (T2DM). First-degree relatives of patients with type 2 diabetes mellitus have an increased risk of insulin resistance and a lifetime risk of developing type 2 diabetes of 40%- 80%. Poor physical fitness is a strong indicator of an increased risk of developing diabetes.\n\nLong-term endurance exercise training has been shown to increase insulin sensitivity in sedentary young and elderly individuals, first degree relatives of patients with Type 2 diabetes, glucose intolerant obese, or Type 2 diabetic humans. In type 2 diabetic patients, non-diabetic individuals with IGT and sedentary adults after exercise training of different intensity, different duration and different frequency an increase of insulin sensitivity was found.\n\nHowever, despite the vast knowledge concerning beneficial effects physical activity for the prevention of T2DM (and many other chronic metabolic disorders) to date wide ranging strategies have not been realized satisfactory. Regardless of age, ethnicity, sex or health status the lack of time is the primary reason for the failure to exercise on a regular basis (or is stated as primary reason). Therefore the investigators aimed at investigating whether a controlled endurance/resistance training twice a week over 6 month might be beneficial for healthy, non obese, first degree relatives with T2DM. Therefore the investigators measure parameters associated with the prevention of T2DM like insulin sensitivity, flux through fATPase and fCK, intramyocellular and hepatocellular lipids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First degree relatives of type 2 diabetic patients\n* Age: 18-50 years\n* BMI \\<30 kg/m2 (due to limited MR diameter)\n* Normal routine lab tests (blood cell count, kidney, liver, pancreas, thyroid and neuromuscular function)\n* Availability within the local area throughout the study\n* Ability to understand and sign the consent forms\n\nExclusion Criteria:\n\n* Current smoking\n* Present drug treatment\n* Regular exercise training\n* Contraindications for MRS studies: claustrophobia and metalliferous implants\n* Pregnancy\n* HIV or Hepatitis\n* Acute disease 2 weeks previous to the examination\n* Heart disease\n* Hypertension (RR\\>140/95)\n* Liver disease\n* Kidney disease\n* Pulmonary disease\n* Thyroid disease'}, 'identificationModule': {'nctId': 'NCT01145092', 'acronym': 'RECO2', 'briefTitle': 'Effects of Six Months of Moderate Resistance- Versus Endurance-Training on Muscle ATP Synthesis in First-Degree Relatives of Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Landsteiner Institut'}, 'officialTitle': 'Effects of Six Months of Moderate Resistance- Versus Endurance-Training on Muscle ATP Synthesis in First-Degree Relatives of Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'P15656'}}, 'armsInterventionsModule': {'interventions': [{'name': 'exercise training, endurance training', 'type': 'BEHAVIORAL', 'description': 'The endurance training group exercised on a cycle ergometer (90% of power output determined at the respiratory compensation point = RCP). The duration of each training unit was increased with time. The resistance group trained on 8 weight machines where the workload gradually increased every 2-3 weeks. At week 13 an additional physical examination, OGTT and spiro-ergometry for adjusting the training were performed.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1140', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Landsteiner Institute', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Michael Roden, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institute for Clinical Diabetology, German Diabetes Center (Leibniz Center for Diabetes Research), Department of Metabolic Diseases, Heinrich-Heine University and University Clinics Düsseldorf, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Landsteiner Institut', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mein Hanusch-Krankenhaus', 'class': 'OTHER'}, {'name': 'Karl-Landsteiner Institute for Endocrinology and Metabolism', 'class': 'UNKNOWN'}, {'name': 'Medical University of Vienna', 'class': 'OTHER'}, {'name': 'Lund University', 'class': 'OTHER'}, {'name': 'Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Landsteiner Institute', 'oldOrganization': 'Landsteiner Institute'}}}}