Clinical trial 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
Official title: Effects of Six Months of Moderate Resistance- Versus Endurance-Training on Muscle ATP Synthesis in First-Degree Relatives of Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Insulin Resistance
Keywords: type 2 diabetes
exercise training
ATP-synthesis
intramyocellular lipids
hepatocellular lipids
first degree relatives of T2DM patients
Lead sponsor: Landsteiner Institut
Sponsor class: OTHER
Collaborators: name: Mein Hanusch-Krankenhaus
name: Karl-Landsteiner Institute for Endocrinology and Metabolism
name: Medical University of Vienna
name: Lund University
name: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
First posted: 2010-06-16
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Insulin Sensitivity
Secondary outcomes:
measure: incremental test power, oxygen uptake (VO2 in ml.kg-1.min-1), "aerobic threshold" (RCP= respiratory compensation point)
measure: ATP-Synthesis
measure: liver lipid content
measure: skeletal muscle lipid content
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Landsteiner Institute
Study officials:
affiliation: Institute for Clinical Diabetology, German Diabetes Center (Leibniz Center for Diabetes Research), Department of Metabolic Diseases, Heinrich-Heine University and University Clinics Düsseldorf, Germany
name: Michael Roden, Prof.
role: STUDY_DIRECTOR
References: