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

NCT05662189 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-03-18

No results posted yet for this study

Summary

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.

Conditions

  • Type1diabetes
  • Type2diabetes
  • Pre Diabetes
  • Hyperinsulinism

Interventions

DRUG

68Ga-exendin-4

68Ga-exendin4 PET-CT scan

OTHER

mixed meal test

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

Sponsors & Collaborators

  • University of Parma

    collaborator OTHER

  • Azienda Ospedaliero-Universitaria di Parma

    lead OTHER

Principal Investigators

  • Riccardo Bonadonna, MD · Azienda Ospedaliero Universitaria di Parma, University of Parma

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-15
Primary Completion
2025-07-31
Completion
2025-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05662189 on ClinicalTrials.gov