Fat and Sugar Metabolism During Exercise, With and Without L-carnitine in Patients With Carnitine Transporter Deficiency

What Was Tested

This registered not phased trial tested L-Carnitine.

The investigators wish to investigate fat and sugar metabolism during exercise with and without L-carnitine supplementation in patients with carnitine transporter deficiency (CTD).

Patients with CTD have low plasma- and muscle concentrations of carnitine, which is believed to lead to an impaired fat oxidation.

It had 1 arm (groups): Break in L-carnitine treatment (experimental).

Patients do not take their L-carnitine (Levocarnitine) treatment for 2-4 days until plasma carnitine and acylcarnitine have fallen. While patients abstain from taking the treatment, they are admitted for cardiac telemetry monitoring.

The registry classes the interventions as dietary supplement.

More on the Plan

Subjects arrive at the laboratory after 3-9 hours fasting.

One IV-catheter is inserted in the cubital vein in one arm and another in a peripheral vein in the other hand.

Corn contains larger amounts of C13, which the researchers use as a tracer, and can therefore disturb the measurements.

For two hours the subjects rest while receiving the infusions until the tracers have distributed in the body and reached a steady state.

Who Took Part

14 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Verified diagnosis of CTD.

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: other conditions or diseases that may compromise the outcome of the study; pregnancy or lactation; inability to cooperate carrying out the experiments.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when L-Carnitine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2013-08 with completion listed for 2014-08.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The whole body palmitate and carbohydrate oxidation rate in CTD patients during exercise (time frame: With and without L-carnitine treatment).

It also tracked 1 secondary outcome, for example The maximal oxidative capacity (VO2max) as an indicator of exercise tolerance and performance in CTD patients.

What This Means in Plain Language

Put simply, this is a not phased trial of L-Carnitine in 14 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.