Assessing pancreatic beta cell mass and function in diabetes using PET imaging

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to develop a novel tool for evaluating pancreatic beta cell mass (BCM) and function (BCF) in individuals with type 1 and type 2 diabetes, as well as prediabetes and hyperinsulinism. By utilizing 68Ga-exendin-4 and advanced PET imaging techniques, the study seeks to measure beta cell functional mass (BCFxM) in vivo, providing insights into the pathogenesis of diabetes. The research will involve participants undergoing a mixed meal test alongside PET imaging to assess their beta cell activity and health.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years; ≤ 75 years
* Both sexes
* Good health
* Absence of exclusion criteria
* Able to understand methods, goals, and implications of the research and of delivering a free, written informed consent

Exclusion Criteria:

* Hemoglobin \< 12 g/dl
* HbA1c \> 10%
* Pregnancy or breast-feeding
* If not in menopause, women not using effective birth control methods or not willing to undergo a pregnancy test
* History of severe psychiatric disorder or alcohol abuse
* Recent head traumas (\<6 months)
* Active neurologic diseases
* Claustrophobia
* Active malignant neoplasms
* Severe kidney and/or liver disease
* Recent (\<6 months) major adverse cardiovascular events
* Heart failure (class NYHA 3-4)
* Drugs known to affect beta cell function and/or insulin sensitivity
* Current or past treatment with GLP1R-agonists
* Intolerance to exenatide
* Endocrine diseases, other than diabetes mellitus, known to affect beta cell function and/or insulin sensitivity, except well controlled hypothyroidism or adrenal insufficiency
* COPD on day time oxygen therapy
* Any current acute disease

Where it's running

• Azienda Ospedaliero Universitaria di Parma
  Parma, Pr, Italy Recruiting

Study contacts

• Principal investigator: Riccardo Bonadonna, MD — Azienda Ospedaliero Universitaria di Parma, University of Parma
• Study coordinator: Riccardo Bonadonna, MD
• Email: riccardo.bonadonna@unipr.it
• Phone: +390521033307

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.