Carnitine Supplementation in Type 2 Diabetic Patients

What Was Tested

In this not phased trial, researchers set out to test L-Carnitine.

The results from animal studies and preliminary human studies show that carnitine availability and acetylcarnitine concentrations are low in insulin resistant states such as with type 2 diabetes mellitus.

It had 1 arm (groups): Experimental: carnitine intervention (in all participants) (experimental).

The registry classes the interventions as drug.

More on the Plan

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

The conversion of acetyl-CoA to acetylcarnitine relieves this acetyl-CoA pressure on PDH.

Subjects will not be blinded for the intervention since all subjects will receive oral carnitine supplementation.

Study population: n=32, patient with type 2 diabetes (BMI 25-38, age 40-75 years) male and female will be included.

Who Took Part

32 actual participants took part.

It was open to people of any sex aged from 40 years up to 75 years.

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

Examples of who could join: Men and woman. Age: 40-75 years. Woman should be postmenopausal. BMI: 25-38 kg/m2. Stable dietary habits.

The full record lists 7 inclusion and 16 exclusion criteria; among the exclusions: uncontrolled hypertension; use of anticoagulants; insulin dependent type 2 diabetic patients.

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 2018-03-01 with completion listed for 2019-11-11.

It ran at 1 site in Netherlands.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Insulin sensitivity (time frame: 2-step hyperinsulinemische-egulycemische clamp (5.5 hours)). Metabolic flexibility (time frame: 2-step hyperinsulinemische-egulycemische clamp (5.5 hours)).

It also tracked 8 secondary outcomes, for example Maximal acetylcarnitine concentrations after exercise, Body composition (bod pod), Intrahepatic lipid content, physical performance, physical performance and Quality of life.

What This Means in Plain Language

Put simply, this is a not phased trial of L-Carnitine in 32 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.