The Effect of Acyl-Ghrelin on Kidney Function and Blood Pressure in Healthy Volunteers

What Was Tested

This registered phase 1 trial tested Ghrelin for low blood pressure and orthostatic hypotension.

Ghrelin (growth hormone release inducer) is produced in the stomach.

The active form of Ghrelin is Acyl-Ghrelin.

Acyl-Ghrelin stimulates the Ghrelin receptors.

It had three arms (groups): one (active comparator), one (active comparator) and Isotonic Sodium Chloride (placebo comparator).

Intravenous injection on examination day.

Intravenous injection on examination day.

Intravenous injection on examination day.

The registry classes the interventions as drug.

Who Took Part

The registry lists 15 planned participants were the target.

It was open to people of any sex aged from 18 years up to 40 years.

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

Examples of who could join: Age 18-40 years,. Women must use contraception.

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: tobacco smoking,; substance abuse,; medical treatment except for contraception,.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Ghrelin and who got the comparison, which limits bias.

In the crossover set-up each of the low blood pressure and orthostatic hypotension 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 2015-05 with completion listed for 2018-01.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Fractional sodium excreation (FENa) (time frame: 5-6 Hours).

It also tracked 4 secondary outcomes, for example Renal function, Water and sodium transport, Vasoactive hormones and Blood pressure.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Ghrelin in 15 people with low blood pressure and orthostatic hypotension.

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, Low blood pressure and orthostatic hypotension research.