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

NCT05662189 | Recruiting

• 1 other identifier: 462
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type1diabetes; Type2diabetes; Pre Diabetes; Hyperinsulinism

Keywords

diabetes; beta-cell; exendin; PET-CT

Outcome Measures

Primary Outcomes (3)

• BCF x M

  BCFxM=parameters derived from mixed meal test Beta cell function(BCF)=BCFxM/BCM

  through study completion, an average of 3 months after enrolment

• pancreatic beta cell mass (BCM)

  Beta cell mass index (BCM) = 68GA-exendin-4 Standard Uptake Value (SUV)\*pancreatic volume

  through study completion, an average of 3 months after enrolment

• pancreatic beta cell function (BCF)

  BCFxM/BCM

  through study completion, an average of 3 months after enrolment

Study Arms (7)

long standing type 1 diabetes (> 20 yrs)

OTHER

68Ga-exendin4 PET-CT scan +mixed meal test

Drug: 68Ga-exendin-4; Other: mixed meal test

newly diagnosed type 1 diabetes (< 5yrs)

OTHER

68Ga-exendin4 PET-CT scan +mixed meal test

Drug: 68Ga-exendin-4; Other: mixed meal test

long standing type 2 diabetes (> 20 yrs)

OTHER

68Ga-exendin4 PET-CT scan +mixed meal test

Drug: 68Ga-exendin-4; Other: mixed meal test

newly diagnosed type 2 diabetes (<6 months)

OTHER

68Ga-exendin4 PET-CT scan +mixed meal test

Drug: 68Ga-exendin-4; Other: mixed meal test

pre-diabetes

OTHER

68Ga-exendin4 PET-CT scan +mixed meal test

Drug: 68Ga-exendin-4; Other: mixed meal test

hyperinsulinemic

OTHER

68Ga-exendin4 PET-CT scan +mixed meal test

Drug: 68Ga-exendin-4; Other: mixed meal test

control

OTHER

68Ga-exendin4 PET-CT scan +mixed meal test

Drug: 68Ga-exendin-4; Other: mixed meal test

Interventions

68Ga-exendin-4 DRUG

68Ga-exendin4 PET-CT scan

control; hyperinsulinemic; long standing type 1 diabetes (> 20 yrs); long standing type 2 diabetes (> 20 yrs); newly diagnosed type 1 diabetes (< 5yrs); newly diagnosed type 2 diabetes (<6 months); pre-diabetes

mixed meal test OTHER

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

control; hyperinsulinemic; long standing type 1 diabetes (> 20 yrs); long standing type 2 diabetes (> 20 yrs); newly diagnosed type 1 diabetes (< 5yrs); newly diagnosed type 2 diabetes (<6 months); pre-diabetes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Parma: lead
• University of Parma: collaborator

Study Sites (1)

Azienda Ospedaliero Universitaria di Parma

Parma, Pr, 43126, Italy

RECRUITING

MeSH Terms

Conditions

Glucose Intolerance; Hyperinsulinism; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Riccardo Bonadonna, MD

  Azienda Ospedaliero Universitaria di Parma, University of Parma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Riccardo Bonadonna, MD

CONTACT

+390521033307; riccardo.bonadonna@unipr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: 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: * Session A (Endocrinology and Metabolic Diseases Unit) - Quantitation of beta cell functional mass (BCFxM) by mixed-meal test * Session B (Nuclear Medicine Unit) - Quantitation of beta cell mass (BCM) by PET-CT scan.

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 22, 2022
• Study Start: March 15, 2022
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

IT (1)