Improving Glycaemic Control With L-carnitine

What Was Tested

The trial (phase 2) is built around L-Carnitine.

A characteristic of Type 2 diabetes is a high blood glucose level, which is partly caused by the inability of insulin to stimulate glucose uptake into their muscles (insulin resistance).

Insulin resistance can be caused by the accumulation of fat within muscle of overweight individuals.

It had two arms (groups): Carnitine (experimental) and Sugar pill (placebo comparator).

Oral administration of placebo sugar pill.

The registry classes the interventions as dietary supplement.

Who Took Part

24 planned participants were the target.

It was open to men only aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Body mass index (BMI) 27-37 kg/m2. Age 18-60 years old. Not taking anti-diabetes medication other than metformin. Understand verbal and/or written explanation of the study requirements.

The full record lists 6 inclusion and 13 exclusion criteria; among the exclusions: malignancy (excluding localised basal and squamous cell skin cancer); metabolic diseases (stable treated hypothyroidism allowed); active cardiovascular disease (current angina, myocardial infarct, or coronary artery surgery/angioplasty within 12 months).

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind L-Carnitine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2014-08 with completion listed for 2016-07.

It ran at 1 site in United Kingdom.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Skeletal muscle total carnitine content (time frame: up to 24 weeks of L-carnitine supplementation).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of L-Carnitine in 24 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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