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

Recruiting now · Not applicable

Conditions studied: Type1diabetes, Type2diabetes, Pre Diabetes, Hyperinsulinism

In brief

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.

Key facts

Study ID

NCT05662189

Run by

Azienda Ospedaliero-Universitaria di Parma

People needed

70

Starts

2022-03-15

Expected to finish

2025-12-01

Last updated by the study team

2025-03-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Azienda Ospedaliero Universitaria di Parma — Parma, Pr, Italy (enrolling)

Full record on ClinicalTrials.gov

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