Effect of Ghrelin on Glucose Metabolism After Bariatric Surgery

What Was Tested

The trial (phase 1) is built around Ghrelin.

The purpose of this study is to determine if the altered nutrient exposure to the GI tract after bariatric surgery reveals a negative incretin effect of ghrelin.

It had four arms (groups): Vertical Sleeve Gastrectomy (VSG) NJ/PO (experimental), Roux-en-Y Gastric Bypass (RYGB) NJ/PO (experimental), Vertical Sleeve Gastrectomy (VSG) PO/PO (experimental) and Roux-en-Y Gastric Bypass (RYGB) PO/PO (experimental).

The registry classes the interventions as drug and procedure.

Who Took Part

70 planned participants were the target.

It was open to people of any sex aged from 21 years up to 65 years.

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

Examples of who could join: BMI ≥ 35 kg/m2. Age 21-65 years. Weight ≤ 200 kg.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: medications that alter insulin sensitivity or carbohydrate metabolism; positive pregnancy test; prior gastric or intestinal surgery or pancreas resection.

How the Study Was Run

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

Because people in this Ghrelin 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 participants took both Ghrelin and the comparison in turn, acting as their own control.

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

Those kept unaware of assignments: participant.

It started in 2016-09 with completion listed for 2019-08-21.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Change in plasma glucose levels with ghrelin versus saline (time frame: 1 month (before and after surgery)).

It also tracked 1 secondary outcome, for example Plasma insulin levels.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Ghrelin in 70 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Ghrelin compound page, all human trials.