mixed meal test: before and after a standardized mixed meal venous blood samples will be collected at time intervals to measure plasma glucose, C-peptide,insulin, glucagon, glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP) curves
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
BCF x M — through study completion, an average of 3 months after enrolment BCFxM=parameters derived from mixed meal test
Beta cell function(BCF)=BCFxM/BCM
pancreatic beta cell mass (BCM) — through study completion, an average of 3 months after enrolment Beta cell mass index (BCM) = 68GA-exendin-4 Standard Uptake Value (SUV)\*pancreatic volume
pancreatic beta cell function (BCF) — through study completion, an average of 3 months after enrolment BCFxM/BCM
Trial sites (1)
Facility
City
Region
Status
Azienda Ospedaliero Universitaria di Parma
Parma
Pr
Recruiting
More Azienda Ospedaliero-Universitaria di Parma trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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