Exenatide and Brown Adipose Tissue

What Was Tested

The trial (phase 4) is built around Exenatide.

Moreover, T2D occurs at a younger age and at a lower BMI when compared to white Caucasians.

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

The registry classes the interventions as drug.

More on the Plan

The current study is an open-label single arm prospective design, including 24 healthy young lean males (BMI between 18 and 25 kg/m2), of whom 12 Dutch South Asians and 12 Dutch Caucasians.

Study subjects will visit the LUMC weekly.

Before and after treatment there will be a study day, in which BAT (by means of 18F-FDG PET-CT scan and MRI scan), resting energy expenditure (measured by indirect calorimetry) and fat mass (by bio-impedance analysis) will be measured.

Moreover, blood will be drawn to investigate the effects of exenatide on lipid- and glucose metabolism.

Who Took Part

24 planned participants were the target.

It was open to men only aged from 20 years up to 30 years.

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

Examples of who could join: Dutch South Asian or white Caucasian male, 20-30 years. BMI ≥ 18 and ≤ 25 kg/m2. Good general health.

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: BMI \> 25 kg/m2 or \< 18 kg/m2; use of medication known to influence glucose and/or lipid metabolism or brown fat activity (e.g. beta blockers); renal, hepatic or endocrine disease.

How the Study Was Run

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

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2016-08 with completion listed for 2018-06.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The effect of exenatide on BAT activity and energy expenditure in healthy young South Asian compared to white Caucasian men (time frame: End of the study, up to 21 months).

It also tracked 1 secondary outcome, for example Visualisation of BAT as measured with MRI scan compared to FDG-PET CT.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Exenatide in 24 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 Exenatide compound page, all human trials.