- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01553968
Effects of Acute Exercise on Acetylcarnitine Concentration in Endurance Trained and Untrained Subjects
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 Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6202 AZ
- Maastricht University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Endurance Trained Subjects
|
30 minutes of cycling at 50% of predetermined maximal performance
|
OTHER: Untrained Subjects
|
30 minutes of cycling at 50% of predetermined maximal performance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
During 30 minutes prior to the exercise and for 30 minutes after exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Substrate oxidation
Time Frame: Measured during the 30 minutes of exercise
|
Measured with indirect calorimetry
|
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 sample of 10 mL
|
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 sample of 10 mL
|
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
|
Blood sample of 10 mL
|
At the start and at the end of 30 minutes of exercise
|
Collaborators and Investigators
Investigators
- Principal Investigator: Vera B. Schrauwen-Hinderling, PhD., Maastricht University Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
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
- 11-2-069
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
US Department of Veterans AffairsAmerican Diabetes AssociationCompletedType 2 Diabetes MellitusUnited States
-
Dexa Medica GroupCompletedType-2 Diabetes MellitusIndonesia
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
AstraZenecaRecruiting
Clinical Trials on Cycling
-
George Fox UniversityRecruitingCan BFR Cycling Augment Strength and VO2peakUnited States
-
Verein zur Förderung der Rehabilitationsforschung...Deutsche Arthrose-Hilfe; Verein zur Förderung der Erforschung und Bekämpfung... and other collaboratorsCompleted
-
University of VigoCompleted
-
VA Office of Research and DevelopmentRecruitingParkinson's DiseaseUnited States
-
Western University, CanadaUnknown
-
Chang Gung Memorial HospitalRecruitingEccentric Exercise TrainingTaiwan
-
UGECAM Rhône-AlpesRecruitingHemiparesis;Poststroke/CVAFrance
-
Université Catholique de LouvainRecruiting
-
Franklin Pierce UniversityTerminatedHyperglycemia, PostprandialUnited States
-
Arizona State UniversityCompletedType2 Diabetes | Disability PhysicalUnited States