Effects of Six Months of Moderate Resistance- Versus Endurance-Training on Muscle ATP Synthesis in First-Degree Relatives of Patients With Type 2 Diabetes (RECO2)

June 15, 2010 updated by: Landsteiner Institut

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.

Long-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.

However, 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

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
      • Vienna, Austria, 1140
        • Landsteiner Institute

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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • First degree relatives of type 2 diabetic patients
  • Age: 18-50 years
  • BMI <30 kg/m2 (due to limited MR diameter)
  • Normal routine lab tests (blood cell count, kidney, liver, pancreas, thyroid and neuromuscular function)
  • Availability within the local area throughout the study
  • Ability to understand and sign the consent forms

Exclusion Criteria:

  • Current smoking
  • Present drug treatment
  • Regular exercise training
  • Contraindications for MRS studies: claustrophobia and metalliferous implants
  • Pregnancy
  • HIV or Hepatitis
  • Acute disease 2 weeks previous to the examination
  • Heart disease
  • Hypertension (RR>140/95)
  • Liver disease
  • Kidney disease
  • Pulmonary disease
  • Thyroid disease

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Insulin Sensitivity
measured by oral glucose tolerance test

Secondary Outcome Measures

Outcome Measure
Measure Description
incremental test power, oxygen uptake (VO2 in ml.kg-1.min-1), "aerobic threshold" (RCP= respiratory compensation point)
This test was performed on an electronically braked cycle ergometer
ATP-Synthesis
measured with 13C NMR
liver lipid content
measured with 1H NMR
skeletal muscle lipid content
measured by 1H NMR

Collaborators and Investigators

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

Sponsor

Landsteiner Institut

Collaborators

Lund University
Medical University of Vienna
Mein Hanusch-Krankenhaus
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Karl-Landsteiner Institute for Endocrinology and Metabolism

Investigators

  • Study Director: Michael Roden, Prof., Institute for Clinical Diabetology, German Diabetes Center (Leibniz Center for Diabetes Research), Department of Metabolic Diseases, Heinrich-Heine University and University Clinics Düsseldorf, Germany

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

February 1, 2006

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

June 14, 2010

First Submitted That Met QC Criteria

June 15, 2010

First Posted (ESTIMATE)

June 16, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 16, 2010

Last Update Submitted That Met QC Criteria

June 15, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P15656

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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