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

October 8, 2010 updated by: Paracelsus Medical University

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, 5020
        • Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strength
Time Frame: 8 weeks
Measruement will be performed using Concept Dyno 2
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle mass
Time Frame: 8 weeks
Muscle mass will be measured using dual X-ray absorbiotometry
8 weeks
Glycemic control
Time Frame: 8 weeks
Fasting blood glucose, HbA1c, and fructosamin will be measured using routine laboratory methods
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paracelsus Medical University

Investigators

  • Principal Investigator: Josef Niebauer, MD, PhD, MBA, Paracelsus Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

October 8, 2010

First Submitted That Met QC Criteria

October 8, 2010

First Posted (Estimate)

October 11, 2010

Study Record Updates

Last Update Posted (Estimate)

October 11, 2010

Last Update Submitted That Met QC Criteria

October 8, 2010

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UISM-2-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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