The Effect of Liraglutide Treatment on Postprandial Chylomicron and VLDL Kinetics, Liver Fat and de Novo Lipogenesis

What Was Tested

The trial (phase 4) is built around Liraglutide.

It had two arms (groups): Liraglutide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The well recognized dyslipidemia in people with type 2 diabetes consists of high fasting and non-fasting plasma triglycerides (TG), low high-density lipoprotein (HDL) -cholesterol and preponderance of small dense low-density lipoprotein (LDL) particles nominated as the atherogenic lipid triad.

Humans are mostly in a postprandial rather than fasting state and therefore non-fasting TG values reflect more accurately the continuous exposure of arterial wall to triglyceride rich lipoproteins (TRLs) and more importantly, to substantial cholesterol load that these particles deliver.

Postprandial lipemia is highly prevalent even in type 2 diabetes patients with normal fasting TG concentrations.

Intestinal overproduction of chylomicrons (CMs) and the structural protein apolipoprotein (apo)-B48 has been identified as an integral feature of postprandial lipemia in type 2 diabetes and insulin resistance.

Who Took Part

The registry lists 23 actual participants took part.

It was open to people of any sex aged from 30 years up to 75 years.

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

Examples of who could join: Waist circumference \> 88 cm in women and \> 92 cm in men. BMI 27-40 kg/m2.

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: type 1 diabetes; apo e2/2 phenotype; ALT/AST \> 3x ULN.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Because people in this Liraglutide 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.

In this single-blind Liraglutide study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2015-02-01 with completion listed for 2019-02-28.

It ran at 1 site in Finland.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Liver Fat Content (time frame: Baseline and after 16 weeks). Plasma Triglyceride (TG) Area Under Curve (AUC) (time frame: Baseline and after 16 weeks). Body Weight (time frame: Baseline and after 16 weeks).

It also tracked 11 secondary outcomes, for example Change in Systolic RR, Mean Total Production of apoB48, Mean Production Rate of apoB48 in CM, Mean apoB48 FTR to VLDL1 Particles, Mean TG Fractional Catabolic Rates in CM and Mean CM FDC of apoB48.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 23 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Liraglutide compound page, all human trials.