Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia (FAST)
Endogenous Hyperinsulinism
About this trial
This is an interventional basic science trial for Endogenous Hyperinsulinism focused on measuring fasting test, Blood glucose, insulin, proinsulin, C-peptide, betahydroxybutyrate, hypoglycemia
Eligibility Criteria
Patients with suspicion for an insulinoma fulfilling all of the following inclusion criteria are eligible for the study:
Inclusion Criteria:
- Informed Consent as documented by signature
- Biochemically proven endogenous hyperinsulinemic hypoglycemia: neuroglycopenic symptoms in the fasting state with low plasma glucose, inappropriately high serum insulin and C-peptide concentrations (standardized 72h fasting test).).
Participants as control subjects fulfilling all of the following inclusion criteria are eligible for the study:
Inclusion Criteria:
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Possession of the adequate match criteria (age, BMI and gender) to patients with suspicion for an insulinoma
Exclusion Criteria:
- Known hypersensitivity or allergy to Exenatide
- Pregnant or breastfeeding female patients. A pregnancy test will be performed in all women of child bearing potential.
- Calculated creatinine clearance below 40 ml/min
- No signed informed consent
- Intake of any glucagon-like peptide (GLP)-1 analogue (such as Byetta® or Bydureon®[= Exenatide])
- prediabetes or diabetes (HbA1c > 5.7 %)
- Previous abdominal surgery in the gastrointestinal tract
- Any concomitant glucose-lowering drug (i. e. insulin, sulfonyl urea)
- Any known intolerance to standardized meal (Maizena)
- Any uncontrolled significant medical, psychiatric or surgical condition (active infection, unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension, uncontrolled congestive heart disease, etc.) or laboratory findings that might jeopardize the patient's safety or that would limit compliance with the objectives and assessments of the study.
- Any mental conditions which prevent the patient from understanding the type, extent and possible consequences of the study and/or an uncooperative attitude from the patient
Sites / Locations
- University Hospital Basel, Division of Nuclear MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Group A (EHH Patients)
Group B (EHH Patients)
Group C (control subjects)
Group A will receive a placebo injection (0.9% saline solution) on Day 1 and 10μg Exenatide injection on Day 2.
Group B will receive a 10μg Exenatide injection on Day 1 and placebo injection (0.9% saline solution) on Day 2.
Control subjects without evidence for EHH defined by no glucose levels below 3.0 mmol/l during a 7-day CGFS (Freestyle libre) and matched to EHH patients for age, gender and BMI will receive only on one study day a single intravenous injection of 10μg Exenatide and compared to group A patients on Day 2. They will not receive a Placebo injection.