Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Switzerland
University Hospital Basel, Division of Nuclear Medicine
Basel
Time Frame
Start Date: 2021-04-29
Completion Date: 2024-04-30
Participants
Target number of participants: 29
Treatments
Experimental: Group A (EHH Patients)
Group A will receive a placebo injection (0.9% saline solution) on Day 1 and 10μg Exenatide injection on Day 2.
Experimental: Group B (EHH Patients)
Group B will receive a 10μg Exenatide injection on Day 1 and placebo injection (0.9% saline solution) on Day 2.
Experimental: Group C (control subjects)
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.
Sponsors
Leads: University Hospital, Basel, Switzerland
Collaborators: Gottfried und Julia Bangerter-Rhyner-Stiftung

This content was sourced from clinicaltrials.gov