NCT05662189 Assessment of Pancreatic Beta Cell Mass and Function by Positron Emission Tomography Imaging in Human Diabetes Mellitus
| NCT ID | NCT05662189 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Ospedaliero-Universitaria di Parma |
| Condition | Type1diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2022-03-15 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2022-03-15 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Riccardo Bonadonna, MD
PRINCIPAL INVESTIGATOR
Azienda Ospedaliero Universitaria di Parma, University of Parma
Frequently Asked Questions
Who can join the NCT05662189 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Type1diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05662189 currently recruiting?
Yes, NCT05662189 is actively recruiting participants. Contact the research team at riccardo.bonadonna@unipr.it for enrollment information.
Where is the NCT05662189 trial being conducted?
This trial is being conducted at Parma, Italy.
Who is sponsoring the NCT05662189 clinical trial?
NCT05662189 is sponsored by Azienda Ospedaliero-Universitaria di Parma. The principal investigator is Riccardo Bonadonna, MD at Azienda Ospedaliero Universitaria di Parma, University of Parma. The trial plans to enroll 70 participants.
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