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Secondary Prevention in Type 2 Diabetes: Comparison of Two Different Resistance Exercise Training Protocols

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ClinicalTrials.gov Identifier: NCT01218256
Recruitment Status : Completed
First Posted : October 11, 2010
Last Update Posted : October 11, 2010
Sponsor:
Information provided by:
Paracelsus Medical University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Other: Physical exercise training Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : July 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Hypertrophy resistance training
Aerobic endurance training combined with hypertrophy resistance training in type 2 diabetes mellitus.
 Other: Physical exercise training
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)
Other Names:
  • training intervention
  • resistance training
Active Comparator: Endurance resistance training
Aerobic endurance training combined with hypertrophy resistance training in type 2 diabetes mellitus.
 Other: Physical exercise training
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)
Other Names:
  • training intervention
  • resistance training


Outcome Measures
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Primary Outcome Measures :
  1. Muscle strength [ Time Frame: 8 weeks ]
    Measruement will be performed using Concept Dyno 2


Secondary Outcome Measures :
  1. Muscle mass [ Time Frame: 8 weeks ]
    Muscle mass will be measured using dual X-ray absorbiotometry

  2. Glycemic control [ Time Frame: 8 weeks ]
    Fasting blood glucose, HbA1c, and fructosamin will be measured using routine laboratory methods


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • type 2 diabetes mellitus

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01218256


Locations
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Austria
Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University
Salzburg, Austria, 5020
Sponsors and Collaborators
Paracelsus Medical University
Investigators
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Principal Investigator: Josef Niebauer, MD, PhD, MBA Paracelsus Medical University
More Information
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Additional Information:

Publications:

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Responsible Party: Professor Josef Niebauer, MD, PhD, MBA, Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University, Lindhofstrasse 20, 5020 Salzburg
ClinicalTrials.gov Identifier: NCT01218256    
Other Study ID Numbers: UISM-2-2010
First Posted: October 11, 2010    Key Record Dates
Last Update Posted: October 11, 2010
Last Verified: June 2007
Keywords provided by Paracelsus Medical University:
diabetes mellitus
type 2 diabetes
T2DM
 resistance training
hypertrophy training
endurance training
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases