A GLP-1 Receptor PET Imaging Substudy Within the VER-A-T1D Trial Investigating the Effects on Beta Cell Mass
Ver-A-image
1 other identifier
interventional
30
2 countries
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 diabetes-mellitus
Started Jul 2021
Typical duration for phase_2 diabetes-mellitus
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2020
CompletedFirst Posted
Study publicly available on registry
November 4, 2020
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedDecember 8, 2023
December 1, 2023
3.8 years
October 22, 2020
December 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pancreatic 68Ga-exendin uptake
the total pancreatic uptake of 68Ga-NODAGA-exendin by PET/CT for determination of beta cell mass
Change from time of inclusion to 12 months into treatment
Secondary Outcomes (2)
Correlation of 68Ga-exendin uptake and C-peptide
12 months into treatment
relative 68Ga-exendin uptake
12 months into treatment
Study Arms (2)
Verapamil
EXPERIMENTALPatients treated with Verapamil within the Ver-A-T1D trial
Placebo
PLACEBO COMPARATORPatients treated with placebo within the Ver-A-T1D trial
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radboud University Medical Centerlead
- Assistance Publique - Hôpitaux de Pariscollaborator
- Medical University of Viennacollaborator
- Bart's Londoncollaborator
- KU Leuvencollaborator
Study Sites (2)
University of Vienna
Vienna, Austria
Assistance Publique hopitaux de Paris
Paris, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2020
First Posted
November 4, 2020
Study Start
July 1, 2021
Primary Completion
April 1, 2025
Study Completion
July 1, 2025
Last Updated
December 8, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share