Ghrelin Effect on Beta Cell Function in Health and Disease

What Was Tested

This registered not phased trial tested Ghrelin.

To determine the role of nutrient status on ghrelin regulation of insulin secretion.

The researchers hypothesize that ghrelin and glucagon-like peptide-1 (GLP-1)(both are hormones made in the gut,) have differential effects on β-cell function in the fed state.

The researchers will compare insulin secretion and glucose turnover during meal ingestion using a dual glucose tracer and mixed meal protocol in subjects receiving ghrelin or saline.

It had four arms (groups): saline (placebo comparator), ghrelin and exendin (9-39) (experimental), Exendin (9-39) (experimental) and ghrelin (experimental).

Ghrelin+Ex-9: Combination of ghrelin and Ex-9,.

The registry classes the interventions as drug.

More on the Plan

A 240-minute meal tolerance test (MTT) using a dual glucose tracer method will serve as the foundation of each study visit.

One tracer, \[6,6-2H2\]glucose will be infused intravenously before and during the test meal to quantify fasting endogenous glucose production (EGP), and glucose disappearance during the meal.

A second tracer, \[U-13C\]glucose, will be included in the meal to trace the appearance of oral glucose.

The systemic appearance rates of both ingested tracer and total (i.e., ingested and endogenously produced) glucose will be calculated.

Who Took Part

The registry lists 30 planned participants were the target.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: Ages between 18 and 45 years. BMI between 18 and 29 kg/m2.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: history of pituitary or adrenal disorders or neuroendocrine tumor; use of medications that alter glucose metabolism; pregnancy or lactation.

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.

In this single-blind Ghrelin study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2013-04 with completion listed for 2014-04.

It ran at 2 sites in United States (2).

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: post-prandial insulin secretion (time frame: 1 year).

It also tracked 11 secondary outcomes, for example endogenous GLP-1 contribution to postprandial insulin secretion, β-cell response to glucose, insulin sensitivity, fasting EGP, glucose appearance and EGP during MTT.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Ghrelin in 30 people.

Its size is small, so on its own it can only give an early look.

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

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