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

NCT05662189 · Recruiting

Last updated 2026-05-28

This clinical trial is testing a PET imaging method to measure the function and amount of insulin-producing cells in the pancreas of adults with type 1 diabetes, type 2 diabetes, prediabetes, or high insulin levels.

Status Recruiting Currently enrolling participants.

Phase Not applicable Not a phased drug trial (e.g. a device or behavioral study).

Type Interventional (clinical trial)

Design Non-randomized, open-label (no blinding) basic-science study

Participants 70 people Planned (estimated).

Who can join Ages 18–75 · all sexes

Timeline Started 2022-03 · est. completion 2025-12

Where 1 site · Italy

What this study is testing ClinicalTrials.gov NCT05662189 ↗

Description as written by the study sponsor.

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.

Treatments tested

68Ga-exendin-4 Drug

68Ga-exendin4 PET-CT scan
mixed meal test Other

before and after a standardized mixed meal venous blood samples will be collected at time intervals to measure plasma glucose, C-peptide,insulin, glucagon, glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP) curves

Main thing measured	BCF x M
Sponsor	Azienda Ospedaliero-Universitaria di Parma
Conditions studied	Type1diabetes, Type2diabetes, Pre Diabetes, Hyperinsulinism
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05662189 ↗