Imaging Pituitary ActiVation by Exendin

What Was Tested

In this not phased trial, researchers set out to test Exenatide.

The main goal is the comparison of pituitary uptake of Ga-68-NODAGA-exendin-4 in patients with and without adequate response (based on HbA1c or weight loss) to GLP-1R agonist treatment.

It had two arms (groups): Patient group with treatment response (other) and Patient group without treatment response (other).

PET/CT imaging of patients with response to GLP-1 receptor agonist treatment.

PET/CT imaging of patients with no response to GLP-1 receptor agonist treatment.

The registry classes the interventions as radiation.

More on the Plan

The glucagon-like peptide 1 receptor agonists (GLP-1RA), such as exendin, can be used as potent antidiabetic drugs for treatment of T2D.

Not all patients with T2D respond to treatment with GLP-1RA and some even respond with contradictory effects, but the underlying mechanism for this observation remains unclear.

Interestingly, uptake of an exendin-based radiotracer was observed in the pituitary gland in diabetes patients.

Patient data will be obtained and will consist of metabolic characterization (laboratory parameters and oral glucose tolerance test), an ACTH assay and determination of cortisol excretion.

Who Took Part

The registry lists 20 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age ≥18 years. Subject is diagnosed with type 2 diabetes. Ability to sign informed consent. Age ≥18 years. Subject is diagnosed with type 2 diabetes.

The full record lists 8 inclusion and 15 exclusion criteria; among the exclusions: liver disease; renal disease; pregnancy or the wish to become pregnant within 6 months after the study.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

The Exenatide group and the comparison group ran side by side rather than switching.

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.

It started in 2019-05-23 with completion listed for 2024-04-03.

It ran at 1 site in Netherlands.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Pituitary uptake of Ga-68-NODAGA-exendin (time frame: 1.5 year).

It also tracked 2 secondary outcomes, for example Metabolic status (OGTT) and Metabolic status (ACTH).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Exenatide in 20 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.