Assessing pancreatic beta cell mass and function in diabetes using PET imaging
Assessment of Pancreatic Beta Cell Mass and Function with the Aid of Positron Emission Tomography Imaging in Human Diabetes Mellitus
NA · Azienda Ospedaliero-Universitaria di Parma · NCT05662189
This study is testing a new imaging tool to see how well the insulin-producing cells in the pancreas are working in people with type 1 and type 2 diabetes, as well as those with prediabetes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliero-Universitaria di Parma (other) |
| Locations | 1 site (Parma, Pr) |
| Trial ID | NCT05662189 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with type 1 or type 2 diabetes, prediabetes, or hyperinsulinism who are in good health.
Not a fit: Patients with severe kidney or liver disease, active malignancies, or those on medications affecting beta cell function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for assessing beta cell function and mass, ultimately enhancing diabetes management.
How similar studies have performed: While the approach of using PET imaging for assessing beta cell function is innovative, similar methodologies have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Parma, Pr
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type1diabetes, Type2diabetes, Pre Diabetes, Hyperinsulinism, diabetes, beta-cell, exendin, PET-CT