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

Launched by AZIENDA OSPEDALIERO-UNIVERSITARIA DI PARMA · Dec 20, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how well the pancreas is working in people with diabetes and obesity. Specifically, it aims to measure both the number of insulin-producing cells in the pancreas and how effectively they function. Researchers will use a special imaging technique called Positron Emission Tomography (PET) to gather this information. This study is important because it will help us understand more about diabetes, including type 1 and type 2, and conditions related to insulin production, like prediabetes and hyperinsulinism.

To participate in the trial, you need to be between 18 and 75 years old and in good health. This means you shouldn't have any major health issues like severe kidney or liver disease, recent heart problems, or active cancer. If you're a woman, you should either be past menopause or using effective birth control. Participants will undergo some tests and imaging to assess their pancreatic function. Joining this study could help advance our understanding of diabetes and potentially improve treatment options for many people.

Gender

ALL

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