Health TrialsbyHealthPanel

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

ConditionsType1diabetesType2diabetesPre DiabetesHyperinsulinism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAzienda Ospedaliero-Universitaria di Parma

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years; ≤ 75 years

Both sexes

Good health

Absence of

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 68Ga-exendin-4

    Drug

    68Ga-exendin4 PET-CT scan

  • mixed meal test

    Other intervention

    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

Treatment groups

70 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: long standing type 1 diabetes (> 20 yrs)Other 2 interventions
Group B: newly diagnosed type 1 diabetes (< 5yrs)Other 2 interventions
Group C: long standing type 2 diabetes (> 20 yrs)Other 2 interventions
Group D: newly diagnosed type 2 diabetes (<6 months)Other 2 interventions
Group E: pre-diabetesOther 2 interventions
Group F: hyperinsulinemicOther 2 interventions
Group G: controlOther 2 interventions

Trial outcomes

Primary outcomes

1

BCF x M

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

Time frame
through study completion, an average of 3 months after enrolment
2

pancreatic beta cell mass (BCM)

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

Time frame
through study completion, an average of 3 months after enrolment
3

pancreatic beta cell function (BCF)

BCFxM/BCM

Time frame
through study completion, an average of 3 months after enrolment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azienda Ospedaliero-Universitaria di Parma

Lead sponsor

University of Parma

Collaborator

Source ClinicalTrials.gov
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