Assessment of Pancreatic Beta Cell Mass and Function by Positron Emission Tomography Imaging in Human Diabetes Mellitus

What Was Tested

The trial (not phased) is built around Exenatide.

The goals of this project are to build an experimental tool to dissect out in vivo pancreatic beta cell mass (BCM) and beta cell function (BCF) and to assess for the first time these two determinants of beta cell functional mass (BCFxM) in obesity and in various stages of type 1 and type 2 diabetes mellitus.

It had seven arms (groups): long standing type 1 diabetes (> 20 yrs) (other), newly diagnosed type 1 diabetes (< 5yrs) (other), long standing type 2 diabetes (> 20 yrs) (other), newly diagnosed type 2 diabetes (<6 months) (other) and pre-diabetes (other).

68Ga-exendin4 PET-CT scan +mixed meal test.

68Ga-exendin4 PET-CT scan +mixed meal test.

68Ga-exendin4 PET-CT scan +mixed meal test.

The registry classes the interventions as drug and other.

More on the Plan

Pancreatic beta cell functional mass (BCFxM) can be loosely defined as the product of beta cell mass (BCM) multiplied by beta cell function (BCF).

Current in vivo methods (e.g. hyperglycemic clamp, intravenous glucose tolerance test, oral glucose tolerance test, mixed meal tolerance test) actually assess BCFxM, not beta cell function per se.

Loss of BCFxM is at the heart of the etiology and pathogenesis of both type 1 (2) and type 2 diabetes mellitus.

In the former, destruction of beta cell mass by autoimmune insulitis is the the primary determinant of BCFxM loss.

Who Took Part

70 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Age ≥18 years; ≤ 75 years.

The full record lists 4 inclusion and 19 exclusion criteria; among the exclusions: able to understand methods, goals, and implications of the research and of delivering a free, written informed consent; pregnancy or breast-feeding; history of severe psychiatric disorder or alcohol abuse.

How the Study Was Run

The set-up was non-randomized, 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 2022-03-15 with completion listed for 2025-07.

It ran at 1 site in Italy.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): BCF x M (time frame: through study completion, an average of 3 months after enrolment). pancreatic beta cell mass (BCM) (time frame: through study completion, an average of 3 months after enrolment). pancreatic beta cell function (BCF) (time frame: through study completion, an average of 3 months after enrolment).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Exenatide in 70 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, all human trials.