Deacylated Ghrelin and Beta Cell Function

What Was Tested

This registered not phased trial tested Ghrelin.

Use of human unacylated ghrelin (UAG, also called des-octanoyl ghrelin) to study physiology in healthy subjects.

It had four arms (groups): decaylated ghrelin (experimental), acyl ghrelin (experimental), combined acyl and desacyl ghrelin (experimental) and saline (placebo comparator).

The registry classes the interventions as drug.

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 50 years.

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

Examples of who could join: Ages between 18 and 50 years, inclusive. BMI between 18.5 and 29.9 kg/m2, inclusive.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: A baseline resting systolic blood pressure of less than 100 mm Hg; history of growth hormone deficiency or excess disorders (acromegaly, pituitary gigantism, panhypopituitarism); history of adrenal insufficiency or cushing's disease/syndrome; history of neuroendocrine tumors; use of medications that alter insulin sensitivity: niacin, glucocorticoids, metformin, thiazolidinediones, exenatide, or atypical anti-psychotics.

How the Study Was Run

It was run as a randomized, crossover and single-blind study.

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 2011-02 with completion listed for 2013-04.

It ran at 1 site in United States.

What Was Measured

The main thing measured (primary outcome): acute insulin release (AIRg) (time frame: one year).

It also tracked 3 secondary outcomes, for example Insulin sensitivity, Disposition index and glucose tolerance.

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.