GLP-1 Receptor Expression in CHI
GLP-1-CHI
The Physiology of Glucagon-like-peptide-1 Espression in Patients With Endogenous Hyperinsulinism: Correlation With Histopathology
1 other identifier
observational
40
1 country
1
Brief Summary
The primary objective is the in vivo and ex vivo investigation of the expression and distribution of the GLP-1R in the pancreas of CHI patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2018
Shorter than P25 for all trials
1 active site
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
Study Start
First participant enrolled
February 7, 2018
CompletedFirst Submitted
Initial submission to the registry
July 11, 2018
CompletedFirst Posted
Study publicly available on registry
December 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedDecember 7, 2018
December 1, 2018
12 months
July 11, 2018
December 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Expression and distribution of GLP-1R in pancreas of children with CHI
Comparison of PET quantification with autoradiography and histology
1 year
Secondary Outcomes (1)
Comparison of the exendin PET/CT and F-DOPA PET/CT
1 year
Interventions
68Ga-exendin-4 PET/CT
Eligibility Criteria
patients (\<16 years) with biochemically proven endogenous congenital hyperinsulinism
You may qualify if:
- Biochemically and clinically proven endogenous congenital hyperinsulinism:
- Unresponsive to medical treatment (diazoxide)
- Indication for 18F-DOPA PET/CT based on mutation analysis
- Standard imaging (18F-DOPA PET/CT) not older than 8 weeks
- \<16 years old
- Informed consent signed by parents or legal guardians of the patient.
You may not qualify if:
- Genetically proven diffuse CHI (presenting with a homozygous or compound heterozygous ABCC8/KCNJ11 mutation)
- Calculated creatinine clearance below 40 ml/min
- Evidence of other malignancy than insulin producing tumors in conventional imaging (suspicious liver, bone and lung lesions based on CT)
- Age \> 16 years
- No signed informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radboud University Medical Centerlead
- European Commissioncollaborator
- University College, Londoncollaborator
- Charite University, Berlin, Germanycollaborator
- University Hospital, Basel, Switzerlandcollaborator
- Insel Gruppe AG, University Hospital Berncollaborator
- University of Helsinkicollaborator
- Turku University Hospitalcollaborator
- University Medical Center Groningencollaborator
Study Sites (1)
Radboudumc
Nijmegen, 6500HB, Netherlands
Biospecimen
Tumour tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Gotthardt, Prof.
Radboud University Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 11, 2018
First Posted
December 7, 2018
Study Start
February 7, 2018
Primary Completion
February 1, 2019
Study Completion
February 1, 2019
Last Updated
December 7, 2018
Record last verified: 2018-12