Status:
COMPLETED
Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborating Sponsors:
Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel
Conditions:
Endogenous Hyperinsulinism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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).
Detailed Description
Endogenous hyperinsulinemic hypoglycemia (EHH) is defined as inappropriate endogenous insulin secretion leading to hypoglycemia and associated symptoms. The most frequent diagnosis is an insulin-secre...
Eligibility Criteria
Inclusion
- Patients with suspicion for an insulinoma fulfilling all of the following inclusion criteria are eligible for the study:
- 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:
- 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
- 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
Key Trial Info
Start Date :
April 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04909333
Start Date
April 29 2021
End Date
April 30 2024
Last Update
May 8 2024
Active Locations (1)
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1
University Hospital Basel, Division of Nuclear Medicine
Basel, Switzerland, 4031