Actively Recruiting
Assessment of Pancreatic Beta Cell Mass and Function with Positron Emission Tomography Imaging in Human Diabetes Mellitus
Led by Azienda Ospedaliero-Universitaria di Parma · Updated on 2025-03-18
70
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
A
Azienda Ospedaliero-Universitaria di Parma
Lead Sponsor
U
University of Parma
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating pancreatic beta cell functional mass (BCFxM), which is the product of beta cell mass (BCM) and beta cell function (BCF). This study aims to measure these two factors in people with obesity and various stages of type 1 and type 2 diabetes mellitus. The loss of BCFxM is central to the development and progression of both types of diabetes, and this research uses advanced imaging to improve understanding of these changes over time. The study involves using 68Ga-exendin-4 PET-CT scans combined with a mixed meal test to evaluate beta cell mass and function. Participants include groups with long-standing and newly diagnosed type 1 and type 2 diabetes, pre-diabetes, hyperinsulinemic individuals, and controls. Each participant will undergo the PET-CT scan and mixed meal test to collect detailed measurements of pancreatic beta cell activity. Participants will be monitored for about three months after enrollment. During this time, researchers will assess pancreatic beta cell mass, beta cell function, and their combined functional mass using imaging and blood tests. The mixed meal test involves collecting blood samples to measure glucose, C-peptide, insulin, glucagon, and related hormones. The study focuses on understanding these measures across different groups to better characterize diabetes progression and beta cell health.
CONDITIONS
Brief Title
Assessment of Pancreatic Beta Cell Mass and Function by Positron Emission Tomography Imaging in Human Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and 75 years or younger
- Both sexes
- Good health
- Able to understand the research methods, goals, and implications
- Willing to provide free, written informed consent
You will not qualify if you...
- Hemoglobin less than 12 g/dl
- HbA1c greater than 10%
- Pregnancy or breastfeeding
- Women not in menopause who are not using effective birth control or unwilling to undergo pregnancy testing
- History of severe psychiatric disorder or alcohol abuse
- Recent head trauma within 6 months
- Active neurological diseases
- Claustrophobia
- Active malignant tumors
- Severe kidney and/or liver disease
- Recent major adverse cardiovascular events within 6 months
- Heart failure classified as NYHA class 3-4
- Use of drugs affecting beta cell function or insulin sensitivity
- Current or past treatment with GLP1 receptor agonists
- Intolerance to exenatide
- Endocrine diseases affecting beta cell function or insulin sensitivity, except well-controlled hypothyroidism or adrenal insufficiency
- COPD requiring daytime oxygen therapy
- Any current acute illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants undergo a 68Ga-exendin-4 PET-CT scan and a mixed meal test to assess pancreatic beta cell mass and function.
1 visit (in-person)
Duration - Approximately 3 months
Participants are observed for an average of 3 months after enrollment to assess beta cell function and mass over time.
Follow-up visits as needed for assessments
Trial Site Locations
Total: 1 location
1
Azienda Ospedaliero Universitaria di Parma
Parma, Pr, Italy, 43126
Actively Recruiting
Research Team
R
Riccardo Bonadonna, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
7
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