Influence of Physical Training on Mitochondrial Function in Type 2 Diabetic Patients

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00365495
• Other study ID #: 022
• Status: Active, not recruiting
• Phase: N/A
• First received: August 15, 2006
• Last updated: April 3, 2007
• Start date: August 2006
• Est. completion date: June 2007

Study information

• Verified date: April 2007
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Procedure:
• Physical training (aerobic training)

Locations

Country	Name	City	State
Denmark	University of Southern Denmark and Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mitochondrial respiratory measurements. The investigations are carried out by two rounds - one before Christmas and one after.
Secondary	VO2max
Secondary	Lipid oxidation
Secondary	muscle fiber type composition
Secondary	muscle oxidative enzymes
Secondary	mitochondrial-specific proteins (UCP3)
Secondary	mitochondrial production of free oxygen radicals