Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-01-04 @ 5:56 PM
Study NCT ID:
NCT01218256
Status:
COMPLETED
Last Update Posted:
2010-10-11
First Post:
2010-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Secondary Prevention in Type 2 Diabetes: Comparison of Two Different Resistance Exercise Training Protocols
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'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D055070', 'term': 'Resistance 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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-08', 'studyFirstSubmitDate': '2010-10-08', 'studyFirstSubmitQcDate': '2010-10-08', 'lastUpdatePostDateStruct': {'date': '2010-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': '8 weeks', 'description': 'Measruement will be performed using Concept Dyno 2'}], 'secondaryOutcomes': [{'measure': 'Muscle mass', 'timeFrame': '8 weeks', 'description': 'Muscle mass will be measured using dual X-ray absorbiotometry'}, {'measure': 'Glycemic control', 'timeFrame': '8 weeks', 'description': 'Fasting blood glucose, HbA1c, and fructosamin will be measured using routine laboratory methods'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes mellitus', 'type 2 diabetes', 'T2DM', 'resistance training', 'hypertrophy training', 'endurance training'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '11527646', 'type': 'BACKGROUND', 'citation': "Maiorana A, O'Driscoll G, Cheetham C, Dembo L, Stanton K, Goodman C, Taylor R, Green D. The effect of combined aerobic and resistance exercise training on vascular function in type 2 diabetes. J Am Coll Cardiol. 2001 Sep;38(3):860-6. doi: 10.1016/s0735-1097(01)01439-5."}, {'pmid': '16084803', 'type': 'BACKGROUND', 'citation': 'Cauza E, Hanusch-Enserer U, Strasser B, Ludvik B, Metz-Schimmerl S, Pacini G, Wagner O, Georg P, Prager R, Kostner K, Dunky A, Haber P. The relative benefits of endurance and strength training on the metabolic factors and muscle function of people with type 2 diabetes mellitus. Arch Phys Med Rehabil. 2005 Aug;86(8):1527-33. doi: 10.1016/j.apmr.2005.01.007.'}, {'pmid': '16761076', 'type': 'BACKGROUND', 'citation': 'Castaneda F, Layne JE, Castaneda C. Skeletal muscle sodium glucose co-transporters in older adults with type 2 diabetes undergoing resistance training. Int J Med Sci. 2006;3(3):84-91. doi: 10.7150/ijms.3.84. Epub 2006 May 17.'}, {'pmid': '11559268', 'type': 'BACKGROUND', 'citation': 'Boule NG, Haddad E, Kenny GP, Wells GA, Sigal RJ. Effects of exercise on glycemic control and body mass in type 2 diabetes mellitus: a meta-analysis of controlled clinical trials. JAMA. 2001 Sep 12;286(10):1218-27. doi: 10.1001/jama.286.10.1218.'}, {'pmid': '18364704', 'type': 'BACKGROUND', 'citation': 'Dunstan DW. Aerobic exercise and resistance training for the management of type 2 diabetes mellitus. Nat Clin Pract Endocrinol Metab. 2008 May;4(5):250-1. doi: 10.1038/ncpendmet0790. Epub 2008 Mar 25. No abstract available.'}, {'pmid': '17876019', 'type': 'BACKGROUND', 'citation': "Sigal RJ, Kenny GP, Boule NG, Wells GA, Prud'homme D, Fortier M, Reid RD, Tulloch H, Coyle D, Phillips P, Jennings A, Jaffey J. Effects of aerobic training, resistance training, or both on glycemic control in type 2 diabetes: a randomized trial. Ann Intern Med. 2007 Sep 18;147(6):357-69. doi: 10.7326/0003-4819-147-6-200709180-00005."}, {'pmid': '18280441', 'type': 'BACKGROUND', 'citation': 'Ibanez J, Gorostiaga EM, Alonso AM, Forga L, Arguelles I, Larrion JL, Izquierdo M. Lower muscle strength gains in older men with type 2 diabetes after resistance training. J Diabetes Complications. 2008 Mar-Apr;22(2):112-8. doi: 10.1016/j.jdiacomp.2007.06.008.'}, {'pmid': '15232701', 'type': 'BACKGROUND', 'citation': 'Tokmakidis SP, Zois CE, Volaklis KA, Kotsa K, Touvra AM. The effects of a combined strength and aerobic exercise program on glucose control and insulin action in women with type 2 diabetes. Eur J Appl Physiol. 2004 Aug;92(4-5):437-42. doi: 10.1007/s00421-004-1174-6.'}, {'pmid': '15735205', 'type': 'BACKGROUND', 'citation': 'Ibanez J, Izquierdo M, Arguelles I, Forga L, Larrion JL, Garcia-Unciti M, Idoate F, Gorostiaga EM. Twice-weekly progressive resistance training decreases abdominal fat and improves insulin sensitivity in older men with type 2 diabetes. Diabetes Care. 2005 Mar;28(3):662-7. doi: 10.2337/diacare.28.3.662.'}], 'seeAlsoLinks': [{'url': 'http://www.salk.at/sportmedizin.html', 'label': 'Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University'}]}, 'descriptionModule': {'briefSummary': 'Skeletal muscle accounts for up to 40% of the total body weight and is responsible for approximately 75% of the whole body insulin-stimulated glucose uptake. Resistance training has been shown to improve insulin-stimulated glucose uptake in patients with T2DM. Therefore the investigators aim to compose the effects of 2 different resistance training protocols in combination with aerobic endurance training (AET) on muscle strength, muscle mass and glycemic control in type 2 diabetes mellitus patients (T2DM).\n\nThe investigators aim to perform an 8 week randomized controlled training intervention in 32 T2DM patients. Patients will be randomly assigned to AET (cycle ergometer, 60-70% of heart rate reserve) combined with hypertrophy resistance training (HRT, n=16, 2 sets, 10-12 repetitions, 70% of the one-repetition maximum) or with endurance resistance training (ERT, n=16, 2 sets, 25-30 repetitions, 40% of the one-repetition maximum). Body composition, blood analyses, physical work capacity and muscle strength will be measured pre- and post-intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 2 diabetes mellitus\n\nExclusion Criteria:\n\n* myocardial infarction within the last 6 months\n* unstable angina pectoris\n* left ventricular ejection fraction less than 40%\n* orthopedic limitations that eliminate to perform resistance training'}, 'identificationModule': {'nctId': 'NCT01218256', 'briefTitle': 'Secondary Prevention in Type 2 Diabetes: Comparison of Two Different Resistance Exercise Training Protocols', 'organization': {'class': 'OTHER', 'fullName': 'Paracelsus Medical University'}, 'officialTitle': 'Combined Resistance and Endurance Training in Patients With Type 2 Diabetes: A Pilot-study to Assess the Effects of 2 Different Resistance Protocols on Muscle Mass, Strength and Glycemic Control.', 'orgStudyIdInfo': {'id': 'UISM-2-2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hypertrophy resistance training', 'description': 'Aerobic endurance training combined with hypertrophy resistance training in type 2 diabetes mellitus.', 'interventionNames': ['Other: Physical exercise training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Endurance resistance training', 'description': 'Aerobic endurance training combined with hypertrophy resistance training in type 2 diabetes mellitus.', 'interventionNames': ['Other: Physical exercise training']}], 'interventions': [{'name': 'Physical exercise training', 'type': 'OTHER', 'otherNames': ['training intervention', 'resistance training'], 'description': 'aerobic endurance training (cycle ergometer, 60-70% heart rate reserve) hypertrophy resistance training (2sets, 10-12 repetitions, 70% of the one-repetition maximum) endurance resistance training (2 sets, 25-30 repetitions, 40% of the one-repetition maximum)', 'armGroupLabels': ['Endurance resistance training', 'Hypertrophy resistance training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}], 'overallOfficials': [{'name': 'Josef Niebauer, MD, PhD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Paracelsus Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paracelsus Medical University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Professor Josef Niebauer, MD, PhD, MBA', 'oldOrganization': 'Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University, Lindhofstrasse 20, 5020 Salzburg'}}}}