Effect of Exenatide on Cortisol Secretion

What Was Tested

This registered phase 4 trial tested Exenatide.

Secondary outcomes involve ACTH and glucose levels.

It had 1 arm (groups): Exenatide (experimental).

The registry classes the interventions as drug.

More on the Plan

Exenatide is a short-acting Glucagon-Like Peptide receptor 1 (GLP-1 R) agonist.

The clinical trial is conducted in10 healthy volunteers.

After that, hormonal and physiological changes are measured during two hours.

The blood samples are taken in 30-minute intervals.

Who Took Part

10 actual participants took part.

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: Age 18-50 years. Body weight \>65 kg.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: presence of chronic illness; daily use of any medicines; pregnancy, lactation.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Exenatide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2017-09-07 with completion listed for 2017-12-28.

It ran at 1 site in Estonia.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: Cortisol peak (time frame: every 30 minutes during 2 hours after injection).

It also tracked 3 secondary outcomes, for example Adrenocorticotropin (ACTH) peak, Glucose and Growth hormone.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Exenatide in 10 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 Exenatide compound page, all human trials.