Congenital Hyperinsulinism Clinical Trial
— GLP-1-CHIOfficial title:
The Physiology of Glucagon-like-peptide-1 Espression in Patients With Endogenous Hyperinsulinism: Correlation With Histopathology
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | February 1, 2019 |
Est. primary completion date | February 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 16 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboudumc | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
Radboud University | Charite University, Berlin, Germany, European Commission, Helsinki University, Turku University Hospital, University College, London, University Hospital Inselspital, Berne, University Hospital, Basel, Switzerland, University Medical Center Groningen |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Expression and distribution of GLP-1R in pancreas of children with CHI | Comparison of PET quantification with autoradiography and histology | 1 year | |
Secondary | Comparison of the exendin PET/CT and F-DOPA PET/CT | Comparison of sensitivity and specificity for localization of focal CHI | 1 year |
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