A GLP-1 Receptor PET Imaging Substudy Within the VER-A-T1D Trial Investigating the Effects on Beta Cell Mass

Trial ID: NCT04615910

Interventional - Phase 2 - Unknown status

The goal of the trial is to measure pancreatic uptake of 68Ga-NODAGA-exendin by PET/CT for detection of intra-individual differences in beta cell mass before and after treatment with Verapamil.

Conditions

• Diabetes Mellitus

Interventions

• 68Ga-NODAGA-exendin-4 PET/CT

Eligibility

Inclusion criteria

• • Have given written informed consent
• • Age ≥18 and \<45 at consent
• • Must have a diagnosis of T1D of within 6 weeks duration at screening (date of the first insulin
• injection)
• • Must have at least one or more diabetes-related autoantibodies present at screening
• • Must have random C-peptide levels ≥200 pmol/L measured at screening
• • Be willing to comply with intensive diabetes management

Exclusion criteria

• Treatment with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors (to exclude interferences with imaging, specifically mentioned although in principle part of exclusion criteria of VER-A-T1D)
• Renal disease defined as MDRD \<40 ml/min/1.73 m2
• Pregnancy or the wish to become pregnant within 2 months after the second PET/CT scan.

Sponsor

Radboud University Medical Center, Assistance Publique - Hôpitaux de Paris, Medical University of Vienna, Bart's London, KU Leuven

Source: ClinicalTrials.gov

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