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

462

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.

2022-03-15

2024-10-01

2024-12-01

Recruiting

70

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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Obese people with normal glucose regulation , patients with long standing or newly diagnosed type 1 diabetes, patients with long standing or newly diagnosed type 2 diabetes, subjects with pre-diabetes, and lean healthy age- and gender-matched controls will participate in two study sessions on two separate days:\n\n* Session A (Endocrinology and Metabolic Diseases Unit) - Quantitation of beta cell functional mass (BCFxM) by mixed-meal test\n* Session B (Nuclear Medicine Unit) - Quantitation of beta cell mass (BCM) by PET-CT scan.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 70, 'type': 'ESTIMATED'}}

2024-01-30