Diabetes Mellitus, Type 2NCT01553968
Effects of Acute Exercise on Acetylcarnitine Concentration in Endurance Trained and Untrained Subjects
A study testing Cycling in people with Diabetes Mellitus, Type 2, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
It has been suggested that imbalance between TCA-cycle flux and β-oxidation may underlie insulin resistance, a predisposing factor for the development of type 2 diabetes mellitus. Acetylcarnitine concentration is suggested to be a marker of such imbalance. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Cycling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2012to Jun 2014
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal weight (BMI 18-25 kg/m2)
- Healthy
- Stable dietary habits
- No use of medication
- VO2-max for trained subjects above 50 mL/min/kg
- VO2-max for untrained subjects below 40 mL/min/kg
Who cannot join
- Any medical condition requiring treatment and/or medication use OR diminishing exercise tolerance
- Alcohol consumption of more than 20 g per day (± 2 units)
- Unstable body weight (weight gain or loss > 3 kg in the past three months)
- Participation in another biomedical study within 1 month prior to the screening visit
- Contraindications for MRI scan:
- Central nervous system aneurysm clips
Show all 12Show fewer
- Implanted neural stimulator
- Implanted cardiac pacemaker of defibrillator
- Cochlear implant
- Iron- containing corpora aliena in the eye or brain
- Hearing aids and artificial (heart) valves which is contraindicated for MRS
- Subjects, who do not want to be informed about unexpected medical findings cannot participate in the study.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6202 AZ
About this study
It has been suggested that imbalance between TCA-cycle flux and β-oxidation may underlie insulin resistance, a predisposing factor for the development of type 2 diabetes mellitus. Acetylcarnitine concentration is suggested to be a marker of such imbalance. It is expected that when TCA-cycle capacity is high (a high oxidative capacity), less acetylcarnitine will accumulate, because of an improved balance between supply and demand of lipids.
The major research objective is to examine if acute exercise results in a more pronounced increase in acetylcarnitine concentration in sedentary subjects compared to endurance-trained subjects and if the exercise-induced increase in acetylcarnitine is restored more quickly in endurance-trained subjects when compared to sedentary subjects.
Read more
The investigators hypothesize that the increase in acetylcarnitine levels will be lower in trained subjects when compared to sedentary subjects, due to a better balance between lipid supply and utilization by the TCA-cycle. Furthermore it is expected that acetylcarnitine concentrations will be restored faster in these trained subjects, because of a tighter regulation of influx of fatty acids.
To test this hypothesis the investigators want to compare the acetylcarnitine response to exercise in a group of sedentary subjects and a group of endurance trained subjects. This response will be measured for 30 minutes after exercise with the use of 1H-MRS.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Cycling
- 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.
CyclingOther
30 minutes of cycling at 50% of predetermined maximal performance
| Study group | Role | What they receive |
|---|---|---|
| Endurance Trained Subjects | Other | Not described Receives: Other: Cycling |
| Untrained Subjects | Other | Not described Receives: Other: Cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise-induced changes in acetylcarnitine concentrations and dynamics of acetylcarnitine restoration after exercise
Acetylcarnitine concentration measured with Proton Magnetic Resonance Spectroscopy (1H-MRS)
Measured: During 30 minutes prior to the exercise and for 30 minutes after exercise
Secondary outcomes (4)
Substrate oxidation
Measured with indirect calorimetry
Measured: Measured during the 30 minutes of exercise
Blood plasma free fatty acids
Blood sample of 10 mL
Measured: At the start and at the end of 30 minutes of exercise
Blood plasma triglycerides
Blood sample of 10 mL
Measured: At the start and at the end of 30 minutes of exercise
Blood plasma glucose
Blood sample of 10 mL
Measured: At the start and at the end of 30 minutes of exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionMar 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vera B. Schrauwen-Hinderling, PhD., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553968
- Sponsor's protocol ID
- 11-2-069
- Status last verified
- Jul 2012
- First submitted
- 7 Mar 2012
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Exercise on Acetylcarnitine Concentration in Endurance Trained and Untrained Subjects
- ClinicalTrials.gov ID
- NCT01553968
- Acronym / sponsor ID
- 11-2-069
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 Mar 2012 (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.
It has been suggested that imbalance between TCA-cycle flux and β-oxidation may underlie insulin resistance, a predisposing factor for the development of type 2 diabetes mellitus. Acetylcarnitine concentration is suggested to be a marker of such imbalance. It is expected that when TCA-cycle capacity is high (a high oxidative capacity), less acetylcarnitine will accumulate, because of an improved balance between supply and demand of lipids.
The major research objective is to examine if acute exercise results in a more pronounced increase in acetylcarnitine concentration in sedentary subjects compared to endurance-trained subjects and if the exercise-induced increase in acetylcarnitine is restored more quickly in endurance-trained subjects when compared to sedentary subjects.
The investigators hypothesize that the increase in acetylcarnitine levels will be lower in trained subjects when compared to sedentary subjects, due to a better balance between lipid supply and utilization by the TCA-cycle. Furthermore it is expected that acetylcarnitine concentrations will be restored faster in these trained subjects, because of a tighter regulation of influx of fatty acids.
To test this hypothesis the investigators want to compare the acetylcarnitine response to exercise in a group of sedentary subjects and a group of endurance trained subjects. This response will be measured for 30 minutes after exercise with the use of 1H-MRS.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endurance Trained Subjects | Other | Other: Cycling |
| Untrained Subjects | Other | Other: Cycling |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Normal weight (BMI 18-25 kg/m2)
- Healthy
- Stable dietary habits
- No use of medication
- VO2-max for trained subjects above 50 mL/min/kg
Key exclusion criteria (12 listed)
- Any medical condition requiring treatment and/or medication use OR diminishing exercise tolerance
- Alcohol consumption of more than 20 g per day (± 2 units)
- Unstable body weight (weight gain or loss > 3 kg in the past three months)
- Participation in another biomedical study within 1 month prior to the screening visit
- Contraindications for MRI scan:
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 |
|---|---|---|
| Cycling30 minutes of cycling at 50% of predetermined maximal performance | Other | Endurance Trained Subjects, Untrained Subjects |
Primary outcome
Exercise-induced changes in acetylcarnitine concentrations and dynamics of acetylcarnitine restoration after exercise
Time frame: During 30 minutes prior to the exercise and for 30 minutes after exercise
Acetylcarnitine concentration measured with Proton Magnetic Resonance Spectroscopy (1H-MRS)
4 secondary outcomes
Substrate oxidation
Time frame: Measured during the 30 minutes of exercise
Blood plasma free fatty acids
Time frame: At the start and at the end of 30 minutes of exercise
Blood plasma triglycerides
Time frame: At the start and at the end of 30 minutes of exercise
Blood plasma glucose
Time frame: At the start and at the end of 30 minutes of exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
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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.
Vera B. Schrauwen-Hinderling, PhD. principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycling in people with Diabetes Mellitus, Type 2, run by Maastricht University Medical Center at 1 site in Netherlands.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 20 Sep 2016. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Exercise-induced changes in acetylcarnitine concentrations and dynamics of acetylcarnitine restoration after exercise (time frame: During 30 minutes prior to the exercise and for 30 minutes after exercise). 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 20 Sep 2016.