Exenatide (Byetta ®) Regulation of Intestinal and Hepatic Lipoprotein Particle Production in Humans

What Was Tested

This registered not phased trial tested Exenatide.

Exenatide acutely inhibits intestinal lipoprotein particle production.

It had 1 arm (groups): exenatide subcutaneous injection (experimental).

Study A: lipoprotein turnover following subcutaneous exenatide administration, under conditions of pancreatic clamp. Study B: lipoprotein turnover study following subcutaneous placebo administration, under conditions of pancreatic clamp.

The registry classes the interventions as drug.

More on the Plan

Subjects will receive an infusion of stable isotope enriched acetate, leucine and a bolus of glycerol in order to measure the rates of fatty acid synthesis, apolipoprotein and triglyceride turnover respectively.

This in vivo stable isotope enrichment methodology has been widely established and used by investigators around the world for more than 30 years to examine the metabolism of various metabolites in humans.

The subject will be allowed to eat regular meals during the day but will fast overnight after 7pm and will remain fasting for the duration of the study.

Water ad lib will be allowed.

Who Took Part

Enrollment: 15 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Men and women, aged 18 to 60 years. Body mass index 20 kg/m2 to 25 kg/m2.

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: subject has a history of hepatitis/hepatic disease that has been active within the previous two years; history of diabetes or ogtt indicative of diabetes or impaired glucose tolerance; any laboratory values: ast \> 2x uln; alt \> 2x uln tsh \> 6 mu/l.

How the Study Was Run

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

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

Only one side, usually the participants, was kept unaware of whether Exenatide was given.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant.

It started in 2010-01 with completion listed for 2011-09.

It ran at 1 site in Canada.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): The objective is to examine the change in apoB48 production rate after one subcutaneous injection of exenatide, under conditions of a pancreatic clamp and a steady state fed state (time frame: over 10 hours).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Exenatide in 15 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 Exenatide compound page, all human trials.