Effects of Intravenous Infusions of Gut Hormones on Appetite and Metabolism.

What Was Tested

The trial (not phased) is built around Peptide YY.

The purpose of this study is to investigate the effects of intravenous infusion of two gastrointestinal hormones, PYY3-36 and GLP-1, alone and in combination, on appetite in healthy obese men.

It had four arms (groups): placebo (placebo comparator), PYY3-36 + GLP-1 (experimental), GLP-1 (active comparator) and PYY3-36 (active comparator).

Study participants will receive a 3 hour IV infusion of saline while fasting.

Study participants will receive a 3 hour IV infusion of (GLP-1 + PYY3-36) while fasting.

Study participants will receive a 3 hour IV infusion of PYY3-36 while fasting.

The registry classes the interventions as biological.

Who Took Part

24 actual participants took part.

It was open to men only aged from 18 years up to 50 years.

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

Examples of who could join: Men age 18-50 years.

The full record lists 3 inclusion and 15 exclusion criteria; among the exclusions: diabetes mellitus; psychological illness; on special diets (eg vegetarian, atkins).

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Peptide YY and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Peptide YY and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Peptide YY.

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

It started in 2011-03 with completion listed for 2012-01.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Ad libitum energy intake (time frame: Immediately following 3h IV infusion).

It also tracked 4 secondary outcomes, for example Energy expenditure (ventilated hood technique), Changes in levels of glucose, insulin, C peptide, GIP, leptin, ghrelin, adiponectin, cholecystokinin, Appetite sensation by visual analog scale and Gastric emptying (paracetamol).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Peptide YY in 24 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 Peptide YY compound page, all human trials.