The Importance of Ghrelin for Glucose Metabolism After Sleeve Gastrectomy

What Was Tested

This registered not phased trial tested Ghrelin.

The overall aim is to delineate the contribution of ghrelin to glucose tolerance after sleeve gastrectomy.

The expectation is therefore that infusion of ghrelin will impair insulin secretion and glucose tolerance compared with a control day without ghrelin infusion.

It had two arms (groups): Gastric sleeve operated (experimental) and Matched control group (placebo comparator).

12 subjects with normal glucose tolerance (NGT) operated with SG minimum 12 month earlier.

12 weight-matched unoperated subjects with NGT.

The registry classes the interventions as other.

More on the Plan

Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) are bariatric procedures.

This present study is complementary to an on-going study in SG operated subjects, where the role of ghrelin for appetite and insulin secretion during a mixed meal followed by an ad libitum meal are investigated.

In the present study the effect of ghrelin on insulin secretion and insulin sensitivity is thoroughly investigated using methods eliminating the effect of other hormones on glucose metabolism.

Specific aim is to evaluate the effect of ghrelin on both alpha and beta cell function as well as on liver and peripheral insulin sensitivity in individuals with SG using matched controls.

Who Took Part

Enrollment: 22 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Sleeve gastrectomy-operated \> 12 months prior to inclusion. Weight stable (+/- 3 kg during the last 3 months). Signed written informed consent.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: pregnancy or breastfeeding; haemoglobin \< 6,5 mm.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

Those kept unaware of assignments: participant.

It started in 2022-01-14 with completion listed for 2023-06-26.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: The difference in disposition index between the two study days with and without ghrelin in fusion in the SG operated group (time frame: 0-180 minutes).

It also tracked 2 secondary outcomes, for example The difference in Insulin sensitivity (M-value) between the two study days with and without ghrelin in fusion in the SG operated group.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Ghrelin in 22 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 Ghrelin compound page, all human trials.