Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia
Switzerland29 participantsStarted 2021-04-29
Plain-language summary
This study is to evaluate the concept of the exenatide test for diagnosis of EHH (earlier induction of symptomatic hypoglycemia compared to placebo within 4 hours after injection).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 contr…
What they're measuring
1
time to symptomatic hypoglycemia after exenatide test compared to placebo