Regulation of Lipoprotein Transport in Metabolic Syndrome

What Was Tested

In this phase 4 trial, researchers set out to test Cardarine (GW501516, non-peptide).

The purpose of this study is to determine whether PPAR-delta agonist (GW5015156)had favorable effect on lipoprotein metabolism.

It had two arms (groups): 1 (placebo comparator) and 2 (active comparator).

Placebo group.

The registry classes the interventions as drug.

More on the Plan

The metabolic syndrome (MetS) portends diabetes and cardiovascular disease (CVD).

GW5015156 is a new PPAR-delta agonist that could be used to treat dyslipidemia in insulin resistance and obesity.

However, the precise mechanisms of action of this agent on lipoprotein kinetics in MetS subjects have not yet fully been investigated.

The researchers therefore carried out a study to study the effect of GW5015156 on lipoprotein transport in subject with metabolic syndrome.

Who Took Part

13 actual participants took part.

It was open to men only aged from 18 years up to 65 years.

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

Examples of who could join: Any three of the following:. Waist circumference \> 102 cm. Blood glucose \> 110 mhg/dL. Blood pressures \> 130/85 mmHg.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: diabetes mellitus; use of agents affecting lipid metabolism; APOE2/E2 genotype.

How the Study Was Run

The set-up was randomized, crossover and triple-blind.

Random assignment meant chance, not the researchers, decided who got Cardarine (GW501516, non-peptide) and who got the comparison, which limits bias.

Each person switched between Cardarine (GW501516, non-peptide) and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Cardarine (GW501516, non-peptide).

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2003-04 with completion listed for 2005-08.

It ran at 1 site in Australia.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): ApoB transport rate (time frame: 5 weeks).

It also tracked 1 secondary outcome, for example ApoA and C-III transport rate.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cardarine (GW501516, non-peptide) in 13 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 Cardarine (GW501516, non-peptide) compound page, all human trials.