Markers of CrAT Protein Activity and Carnitine Availability

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 3, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

November 2018

Estimated Primary Completion Date

June 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Skeletal muscle acetylcarnitine on-kinetic during exercise and carnitine acetyltransferase (CrAT) protein content/activity[ Time Frame: MRS+Exercise test day 2 ]

The correlation between skeletal muscle acetylcarnitine on-kinetic during one-legged exercise and CrAT protein activity will be determined.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Skeletal muscle acetylcarnitine off-kinetic after one-legged exercise and carnitine acetyltransferase (CrAT) protein content/activity[ Time Frame: MRS+Exercise test day 2 ]
The correlation between skeletal muscle acetylcarnitine off-kinetic after one-legged exercise and CrAT protein activity will be determined.
Skeletal muscle CrAT protein activity, from muscle biopsy, and PCr breakdown rate during one-legged exercise[ Time Frame: MRS+Exercise test day 1 ]
The correlation between CrAT protein activity and PCr hydrolysis/breakdown will be determined
Skeletal muscle acetylcarnitine formation capacity upon exercise and total carnitine availability in skeletal muscle[ Time Frame: MRS+Exercise test day 2 ]
The correlation between acetylcarnitine formation upon exercise and total carnitine availability will be determined

Descriptive Information

Brief Title ^ICMJE

Markers of CrAT Protein Activity and Carnitine Availability

Official Title ^ICMJE

Searching for Non-invasive Magnetic Resonance-based Markers for CrAT Protein Activity and Carnitine Availability in Skeletal Muscle

Brief Summary

This study aims to measure skeletal muscle metabolism in vivo during exercise using the non-invasive MRS technique. Specifically, acetylcarnitine and phosphocreatine (PCr) kinetic will be determined at resting, during exercise and during the recovery post exercise. The target population is adult healthy men, with a wide range of maximal physical capacity.

Detailed Description

Dynamic changes in acetylcarnitine during the transition from resting metabolism to exercise (Acetylcarnitine on-kinetic) may modulate the mitochondrial activation speed and CrAT activity may determine the duration of metabolic inertia. Similarly, changes in acetylcarnitine during the sudden decrease in energy demand during the transition from exercise to resting metabolism (acetylcarntine off-kinetic) may also reflect the action of CrAT protein. To date, the only possibility to get information on CrAT activity is by taking a muscle biopsy and perform enzyme activity assays ex vivo. By dynamic MRS scanning, it might be possible to deduce information that reflects CrAT activity, thereby making the biopsy sampling unnecessary.

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Other: Exercise metabolism
Participants will perform a series of exercises inside and outside the MRS/MRI scanner.

Study Arms

: CrAT0X
13 healthy adult men, with a wide range of maximal aerobic capacity will be included. Subjects will be classified as trained, physical active and untrained according to their VO2max. Subject will perform one-legged knee extension and flexion exercise inside the MRS scanner and cycling outside the scanner

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

July 2019

Estimated Primary Completion Date

June 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Males, Generally healthy - Age 18-40 years old - BMI 18 - 25 kg/m2 - No medication use that interfere with the aims of the study - Stable level of daily physical activity or training for at least 6 months Exclusion Criteria: - Females - Regular smokers, drug abuse - Participation in other studies - Weight gain/loss > 3 kg in the last 6 months - Contraindications for MRS scans: - Vegetarian eating behavior

Sex/Gender

Sexes Eligible for Study:

Male

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

，

Study Sponsor ^ICMJE

Maastricht University

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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