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

Sponsor

Landsteiner Institut (Other)

Overall Status

Completed

CT.gov ID

NCT01145092

Collaborator

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

Enrollment

Location

36.9

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus Insulin Resistance	Behavioral: exercise training, endurance training	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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 Start Date :

Feb 1, 2006

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Outcome Measures

Primary Outcome Measures

Insulin Sensitivity []
measured by oral glucose tolerance test

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Landsteiner Institute	Vienna		Austria	1140

Sponsors and Collaborators

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

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