Acute Regulation of Intestinal and Hepatic Lipoprotein Production by Glucagon

What Was Tested

This registered phase 4 trial tested Glucagon.

Insulin resistant states are characterized by hepatic lipoprotein (VLDL) particle overproduction.

Numerous hormonal and nutritional factors are known to influence hepatic lipoprotein particle production, including insulin and free fatty acids (FFA).

In contrast to the liver, the intestine has traditionally been viewed as a 'passive' organ with respect to lipoprotein production, with intestinal lipoprotein particle production determined mainly by the amount of fat ingested and absorbed.

It had two arms (groups): high glucagon (experimental) and low glucagon (experimental).

The registry classes the interventions as drug.

More on the Plan

Potential role of glucagon in intestinal and hepatic lipoprotein production.

Enzymes involved in fatty acid synthesis were not regulated by exogenous glucagon.

To date, glucagon regulation of intestinal lipoprotein production has not been examined in animals or humans.

There is convincing evidence from mouse studies that glucagon plays a major role in the regulation of hepatic lipoprotein production and may also play a role in intestinal lipoprotein assembly and secretion.

Who Took Part

9 actual participants took part.

It was open to people of any sex aged from 18 years up to 40 years.

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

Examples of who could join: Men and women, aged 18 to 40 years. Body mass index 20 kg/m2 to 25 kg/m2.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: subject has a history of hepatitis/hepatic disease that has been active within the previous two years; any laboratory values: ast \> 2x uln; alt \> 2x uln tsh \> 6 mu/l; current addiction to alcohol or substances of abuse as determined by the investigator.

How the Study Was Run

Design: randomized, crossover and single-blind.

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

Each person switched between Glucagon and the comparison at some point, usually with a gap in between.

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

Those kept unaware of assignments: participant.

It started in 2009-06 with completion listed for 2010-01.

It ran at 1 site in Canada.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: Triglyceride-rich lipoprotein production rate (time frame: 0-10 hours).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Glucagon in 9 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 Glucagon compound page, all human trials.