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

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Physical training (aerobic training)
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes, physical training, mitochondrial function

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Southern Denmark and Odense University Hospital

Outcomes

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

Full Information

First Posted
August 15, 2006
Last Updated
April 3, 2007
Sponsor
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00365495
Brief Title
Influence of Physical Training on Mitochondrial Function in Type 2 Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Odense University Hospital

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 diabetes, physical training, mitochondrial function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Physical training (aerobic training)
Primary Outcome Measure Information:
Title
Mitochondrial respiratory measurements. The investigations are carried out by two rounds - one before Christmas and one after.
Secondary Outcome Measure Information:
Title
VO2max
Title
Lipid oxidation
Title
muscle fiber type composition
Title
muscle oxidative enzymes
Title
mitochondrial-specific proteins (UCP3)
Title
mitochondrial production of free oxygen radicals

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Mogensen, PhD student
Organizational Affiliation
University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern Denmark and Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

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