Carnitine Infusion and Insulin Resistance

What Was Tested

In this not phased trial, researchers set out to test L-Carnitine for insulin resistance, prediabetes & type 2 diabetes.

This metabolic inflexibility is an early hallmark in the development of diabetes.

It had three arms (groups): LIPID + Carnitor (experimental), LIPID + PLAC (placebo comparator) and PLAC (placebo comparator).

The registry classes the interventions as dietary supplement and drug.

More on the Plan

Furthermore, a secondary objective is to examine the molecular pathways of carnitine and acetylcarnitine, responsible for muscle insulin sensitivity.

Study design: The current study is an interventional randomized crossover trial in which each subject serves as it owns control.

Subjects will be blinded for the intervention.

Study population: n=10, healthy young (18-40 years) male subjects will be included.

Who Took Part

Enrollment: 17 actual participants took part.

It was open to men only aged from 18 years up to 40 years.

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

Examples of who could join: Age: 18-40 years. Normal BMI: 18-25 kg/m2. Stable dietary habits. No use of medication interfering with investigated study parameters (as determined by responsible physician).

The full record lists 7 inclusion and 17 exclusion criteria; among the exclusions: • female; uncontrolled hypertension; use of anticoagulants.

How the Study Was Run

It was run as a randomized, crossover and single-blind study.

Because people in this L-Carnitine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between L-Carnitine and the comparison at some point, usually with a gap in between.

Only one side, usually the insulin resistance, prediabetes & type 2 diabetes participants, was kept unaware of whether L-Carnitine was given.

Those kept unaware of assignments: participant.

It started in 2016-05 with completion listed for 2017-06.

It ran at 1 site in Netherlands.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Whole body insulin sensitivity (time frame: 6 hours). Metabolic flexibility (time frame: 6-hours).

It also tracked 8 secondary outcomes, for example Maximal acetylcarnitine concentrations after exercise, glucose concentration in the blood before and during insulin stimulation, Carnitine acyltransferase (CRaT) enzyme activity (physiological parameter), Acylcarnitine profile in the muscle (physiological parameter), Lipid levels (physiological parameter) and free fatty acid in the blood before and during insulin stimulation.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 17 people with insulin resistance, prediabetes & type 2 diabetes.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, Insulin resistance, prediabetes & type 2 diabetes research.