- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00365495
Influence of Physical Training on Mitochondrial Function in Type 2 Diabetic Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Odense, Denmark, 5000
- University of Southern Denmark and Odense University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Mitochondrial respiratory measurements. The investigations are carried out by two rounds - one before Christmas and one after.
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Secondary Outcome Measures
Outcome Measure |
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VO2max
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Lipid oxidation
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muscle fiber type composition
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muscle oxidative enzymes
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mitochondrial-specific proteins (UCP3)
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mitochondrial production of free oxygen radicals
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martin Mogensen, PhD student, University of Southern Denmark
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 022 (ITCC)
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