Secondary Prevention in Type 2 Diabetes: Comparison of Two Different Resistance Exercise Training Protocols
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.
1 other identifier
interventional
32
1 country
1
Brief Summary
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). The 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 type-2-diabetes-mellitus
Started Jul 2007
Longer than P75 for phase_1 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 8, 2010
CompletedFirst Posted
Study publicly available on registry
October 11, 2010
CompletedOctober 11, 2010
June 1, 2007
1.4 years
October 8, 2010
October 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Muscle strength
Measruement will be performed using Concept Dyno 2
8 weeks
Secondary Outcomes (2)
Muscle mass
8 weeks
Glycemic control
8 weeks
Study Arms (2)
Hypertrophy resistance training
ACTIVE COMPARATORAerobic endurance training combined with hypertrophy resistance training in type 2 diabetes mellitus.
Endurance resistance training
ACTIVE COMPARATORAerobic endurance training combined with hypertrophy resistance training in type 2 diabetes mellitus.
Interventions
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)
Eligibility Criteria
You may qualify if:
- type 2 diabetes mellitus
You may not qualify if:
- myocardial infarction within the last 6 months
- unstable angina pectoris
- left ventricular ejection fraction less than 40%
- orthopedic limitations that eliminate to perform resistance training
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University
Salzburg, 5020, Austria
Related Publications (9)
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: 11527646BACKGROUNDCauza 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: 16084803BACKGROUNDCastaneda 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: 16761076BACKGROUNDBoule 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: 11559268BACKGROUNDDunstan 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: 18364704BACKGROUNDSigal 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: 17876019BACKGROUNDIbanez 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: 18280441BACKGROUNDTokmakidis 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: 15232701BACKGROUNDIbanez 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.
PMID: 15735205BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Josef Niebauer, MD, PhD, MBA
Paracelsus Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 8, 2010
First Posted
October 11, 2010
Study Start
July 1, 2007
Primary Completion
December 1, 2008
Study Completion
May 1, 2009
Last Updated
October 11, 2010
Record last verified: 2007-06