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NCT Number: NCT01145092

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Landsteiner Institute

Vienna, State of Vienna, 1140, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exercise training, endurance training

Behavioral

The endurance training group exercised on a cycle ergometer (90% of power output determined at the respiratory compensation point = RCP). The duration of each training unit was increased with time. The resistance group trained on 8 weight machines where the workload gradually increased every 2-3 weeks. At week 13 an additional physical examination, OGTT and spiro-ergometry for adjusting the training were performed.

Primary outcomes

  1. Insulin Sensitivity

    measured by oral glucose tolerance test

Secondary outcomes

  1. 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

  2. ATP-Synthesis

    measured with 13C NMR

  3. liver lipid content

    measured with 1H NMR

  4. skeletal muscle lipid content

    measured by 1H NMR

Sponsors and collaborators

Lead sponsor

Landsteiner Institut

Other

Collaborators

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

Registry information

Acronym: RECO2

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jun 16, 2010
Registry last updated
Jun 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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