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NCT05662189
Assessment of Pancreatic Beta Cell Mass and Function by Positron Emission Tomography Imaging in Human Diabetes Mellitus
Conditions: type1diabetes, Type2diabetes, Pre Diabetes, Hyperinsulinism
Sex: All
Ages: 18 Years – 75 Years
Phase: NA
Enrollment: 70
Sponsor: Azienda Ospedaliero-Universitaria di Parma
Location: Italy
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 Criteria
Inclusion Criteria:Age ≥18 years; ≤ 75 yearsBoth sexesGood healthAbsence of exclusion criteriaAble to understand methods, goals, and implications of the research and of delivering a free, written informed consentExclusion Criteria:Hemoglobin < 12 g/dlHbA1c > 10%Pregnancy or breast-feedingIf not in menopause, women not using effective birth control methods or not willing to undergo a pregnancy testHistory of severe psychiatric disorder or alcohol abuseRecent head traumas (<6 months)Active neurologic diseasesClaustrophobiaActive malignant neoplasmsSevere kidney and/or liver diseaseRecent (<6 months) major adverse cardiovascular eventsHeart failure (class NYHA 3-4)Drugs known to affect beta cell function and/or insulin sensitivityCurrent or past treatment with GLP1R-agonistsIntolerance to exenatideEndocrine diseases, other than diabetes mellitus, known to affect beta cell function and/or insulin sensitivity, except well controlled hypothyroidism or adrenal insufficiencyCOPD on day time oxygen therapyAny current acute disease
Source: ClinicalTrials.gov (NCT05662189). StuddyBuddy aggregates publicly available trial information.