RecruitingNot ApplicableNCT05662189

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

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


Sponsor

Azienda Ospedaliero-Universitaria di Parma

Enrollment

70 participants

Start Date

Mar 15, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

  • Age ≥18 years; ≤ 75 years
  • Both sexes
  • Good health

Exclusion Criteria19

  • Able to understand methods, goals, and implications of the research and of delivering a free, written informed consent
  • 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

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Interventions

DRUG68Ga-exendin-4

68Ga-exendin4 PET-CT scan

OTHERmixed 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


Locations(1)

Azienda Ospedaliero Universitaria di Parma

Parma, Pr, Italy

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NCT05662189


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