Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Treatment physical training (aerobic training)
Sponsor Odense University Hospital
Start date August 2006
End date June 2007
Trial size 30 participants
Trial identifier NCT00365495, 022

Summary

Physical activity as treatment for patients with type 2 diabetes (T2D). Treatment of T2D is often done by medication, changing the diet and increased physical activity. It is well established that physical training has a positive effect on the pathology of T2D such as increased insulin sensitivity and reduced fasting plasma glucose (7) and blood lipids (15). It is also well known that in healthy subjects endurance training increases mitochondrial density, lipid oxidation during submaximal exercise, and results in a number of qualitative changes in the control of OXPHOS (24). However, the effect of physical training on the mitochondrial function in skeletal muscle of patients with T2D has not been investigated.

The purpose of this project is to investigate the effect of physical training on the mitochondrial respiratory function in muscles of patients with T2D. Skeletal muscle biopsies will be taken before and after 10 weeks of physical training in patients with T2D and matched control subjects. Mitochondria will be isolated from the muscle biopsies, and respiratory function, free radical production and UCP3 will be determined. Furthermore, measures of maximal oxygen consumption (VO2max), heart rate and capillary lactate concentrations and carbohydrate and lipid oxidation will be determined partly to verify an increased aerobic capacity and partly to investigate the changes in these factors in T2D patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind
Primary purpose treatment

Primary Outcomes

Measure
Mitochondrial respiratory measurements. The investigations are carried out by two rounds - one before Christmas and one after.
time frame:

Secondary Outcomes

Measure
VO2max
time frame:
Lipid oxidation
time frame:
muscle fiber type composition
time frame:
muscle oxidative enzymes
time frame:
mitochondrial-specific proteins (UCP3)
time frame:
mitochondrial production of free oxygen radicals
time frame:

Eligibility Criteria

Male participants from 40 years up to 65 years old.

Inclusion Criteria: - Male, - BMI above 26, - Age between 40 and 65, - Living a sedentary lifestyle Exclusion Criteria: - Women - BMI under 26 - Age under 40 and over 65 - Trained subjects Control subjects: relatives to type 2 diabetic patients, T2D trial subjects

Additional Information

Principal investigator Martin Mogensen, PhD student
Trial information was received from ClinicalTrials.gov and was last updated in April 2007.
Information provided to ClinicalTrials.gov by Odense University Hospital.