Gut Hormones as Mediators of Different Weight Loss Responses After Roux-en-Y Gastric Bypass

What Was Tested

This registered phase 4 trial tested Octreotide for fat loss, obesity & body recomposition.

The purpose of the study is to investigate gut hormone secretion, vagal integrity and the effect of octreotide on ad libitum food intake in patients with suboptimal weight loss after gastric bypass and compare results to a matched group of gastric bypass operated patients with high postoperative weight loss but similar age, sex and preoperative BMI.

It had two arms (groups): Low EBL (other) and High EBL (other).

The registry classes the interventions as other.

Who Took Part

Enrollment: 40 actual participants took part.

It was open to people of any sex aged from 20 years up to 75 years.

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

Examples of who could join: Uncomplicated primary Roux-en-Y gastric bypass \>12 months ago.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: inadequately treated thyroid disease; hemoglobin \<6.5 mm; pregnancy or breastfeeding.

How the Study Was Run

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

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the fat loss, obesity & body recomposition participants took both Octreotide and the comparison in turn, acting as their own control.

Only one side, usually the fat loss, obesity & body recomposition participants, was kept unaware of whether Octreotide was given.

Those kept unaware of assignments: participant.

It started in 2014-10 with completion listed for 2016-12.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Glucagon-like peptide-1 (GLP-1) secretion (Between groups difference in incremental Area-under-the curve (iAUC) GLP-1 after fixed breakfast meal on saline day) (time frame: 0-240 min). Peptide YY (PYY) secretion (Between groups difference in iAUC PYY after fixed breakfast meal on saline day) (time frame: 0-240 min). Ghrelin secretion (Between groups difference in iAUC Ghrelin after fixed breakfast meal on saline day) (time frame: 0-240 min).

It also tracked 3 secondary outcomes, for example Ad libitum food intake.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Octreotide in 40 people with fat loss, obesity & body recomposition.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, Fat loss, obesity & body recomposition research.