Type 2 DiabetesNCT00365495
Influence of Physical Training on Mitochondrial Function in Type 2 Diabetic Patients
A study testing Physical training (aerobic training) in people with Type 2 Diabetes, run by Odense University Hospital at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 40 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Physical training (aerobic training)
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2006to Jun 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male,
- BMI above 26,
- Age between 40 and 65,
- Living a sedentary lifestyle
Who cannot join
- Women
- BMI under 26
- Age under 40 and over 65
- Trained subjects Control subjects: relatives to type 2 diabetic patients, T2D trial subjects
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University of Southern Denmark and Odense University Hospital
Odense, 5000
About this study
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Physical training (aerobic training)
- Keywords
- Type 2 diabetes, physical training, mitochondrial function
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical training (aerobic training)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitochondrial respiratory measurements. The investigations are carried out by two rounds - one before Christmas and one after.
Secondary outcomes (6)
VO2max
Lipid oxidation
muscle fiber type composition
muscle oxidative enzymes
mitochondrial-specific proteins (UCP3)
mitochondrial production of free oxygen radicals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2006 (estimated)
- Study startAug 2006
- Study completionJun 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Martin Mogensen, PhD student, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365495
- Sponsor's protocol ID
- 022
- Status last verified
- Apr 2007
- First submitted
- 15 Aug 2006
- Last updated
- 4 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Physical Training on Mitochondrial Function in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT00365495
- Acronym / sponsor ID
- 022
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, physical training, mitochondrial function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Aug 2006
- Study completion
- Jun 2007 (estimated)
- First posted
- 17 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male,
- BMI above 26,
- Age between 40 and 65,
- Living a sedentary lifestyle
Key exclusion criteria (4 listed)
- Women
- BMI under 26
- Age under 40 and over 65
- Trained subjects Control subjects: relatives to type 2 diabetic patients, T2D trial subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical training (aerobic training) | Procedure or surgery | – |
Primary outcome
Mitochondrial respiratory measurements. The investigations are carried out by two rounds - one before Christmas and one after.
6 secondary outcomes
VO2max
Lipid oxidation
muscle fiber type composition
muscle oxidative enzymes
mitochondrial-specific proteins (UCP3)
mitochondrial production of free oxygen radicals
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Mogensen, PhD student principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical training (aerobic training) in people with Type 2 Diabetes, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mitochondrial respiratory measurements. The investigations are carried out by two rounds - one before Christmas and one after.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2007.