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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Odense University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00365495
First received: August 15, 2006
Last updated: April 3, 2007
Last verified: April 2007
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Procedure: Physical training (aerobic training)

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

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Mitochondrial respiratory measurements. The investigations are carried out by two rounds - one before Christmas and one after.

Secondary Outcome Measures:
  • VO2max
  • Lipid oxidation
  • muscle fiber type composition
  • muscle oxidative enzymes
  • mitochondrial-specific proteins (UCP3)
  • mitochondrial production of free oxygen radicals

Estimated Enrollment: 30
Study Start Date: August 2006
Estimated Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365495

Locations
Denmark
University of Southern Denmark and Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Martin Mogensen, PhD student University of Southern Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00365495     History of Changes
Other Study ID Numbers: 022
Study First Received: August 15, 2006
Last Updated: April 3, 2007
Health Authority: Denmark: National Board of Health

Keywords provided by Odense University Hospital:
Type 2 diabetes
physical training
mitochondrial function

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 29, 2014