Effects of Acute Exercise on Acetylcarnitine Concentration in Endurance Trained and Untrained Subjects
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Cycling
Sponsored by

About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Sites / Locations
- Maastricht University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Endurance Trained Subjects
Untrained Subjects
Arm Description
Outcomes
Primary Outcome Measures
Exercise-induced changes in acetylcarnitine concentrations and dynamics of acetylcarnitine restoration after exercise
Acetylcarnitine concentration measured with Proton Magnetic Resonance Spectroscopy (1H-MRS)
Secondary Outcome Measures
Substrate oxidation
Measured with indirect calorimetry
Blood plasma free fatty acids
Blood sample of 10 mL
Blood plasma triglycerides
Blood sample of 10 mL
Blood plasma glucose
Blood sample of 10 mL
Full Information
NCT ID
NCT01553968
First Posted
March 7, 2012
Last Updated
September 19, 2016
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01553968
Brief Title
Effects of Acute Exercise on Acetylcarnitine Concentration in Endurance Trained and Untrained Subjects
Official Title
Effects of Acute Exercise on Acetylcarnitine Concentration in Endurance Trained and Untrained Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endurance Trained Subjects
Arm Type
Other
Arm Title
Untrained Subjects
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Cycling
Intervention Description
30 minutes of cycling at 50% of predetermined maximal performance
Primary Outcome Measure Information:
Title
Exercise-induced changes in acetylcarnitine concentrations and dynamics of acetylcarnitine restoration after exercise
Description
Acetylcarnitine concentration measured with Proton Magnetic Resonance Spectroscopy (1H-MRS)
Time Frame
During 30 minutes prior to the exercise and for 30 minutes after exercise
Secondary Outcome Measure Information:
Title
Substrate oxidation
Description
Measured with indirect calorimetry
Time Frame
Measured during the 30 minutes of exercise
Title
Blood plasma free fatty acids
Description
Blood sample of 10 mL
Time Frame
At the start and at the end of 30 minutes of exercise
Title
Blood plasma triglycerides
Description
Blood sample of 10 mL
Time Frame
At the start and at the end of 30 minutes of exercise
Title
Blood plasma glucose
Description
Blood sample of 10 mL
Time Frame
At the start and at the end of 30 minutes of exercise
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vera B. Schrauwen-Hinderling, PhD.
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6202 AZ
Country
Netherlands
12. IPD Sharing Statement
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Effects of Acute Exercise on Acetylcarnitine Concentration in Endurance Trained and Untrained Subjects
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