An interventional study of Exenatide and 0.9% saline solution in Endogenous Hyperinsulinism, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Basic science
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).
Endogenous hyperinsulinemic hypoglycemia (EHH) is defined as inappropriate endogenous insulin secretion leading to hypoglycemia and associated symptoms. The most frequent diagnosis is an insulin-secreting pancreatic neuroendocrine tumor, but other diagnoses such as nesidioblastosis of the pancreatic islets are also possible. Biochemically, EHH is characterized by low glucose concentrations in the presence of inappropriately increased C-peptide (endogenous insulin secretion) and insulin levels. The conventional fasting test is at present the gold standard to document EHH.
Radiolabeled Exenatide for localizing insulinomas in patients with biochemically proven EHH has been evaluated and an exenatide-test in an outpatient setting may be able to replace the fasting test, by an early symptomatic hypoglycemia compared to a prolonged inpatient monitoring.
This study is to investigate the concept of the exenatide test to diagnose EHH.
110 studies on the registry are indexed under Hyperinsulinism; 22 are open to participants now.
This study's enrollment of 29 is above the median of 25 across 76 interventional studies indexed under Hyperinsulinism.
Browse Hyperinsulinism studies →University Hospital, Basel, Switzerland is the lead sponsor of 989 studies on the registry; 191 are open to participants now.
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Patients with suspicion for an insulinoma fulfilling all of the following inclusion criteria are eligible for the study:
Inclusion Criteria:
Participants as control subjects fulfilling all of the following inclusion criteria are eligible for the study:
Inclusion Criteria:
Exclusion Criteria:
Group A will receive a placebo injection (0.9% saline solution) on Day 1 and 10μg Exenatide injection on Day 2.
Drug: Exenatide · Drug: 0.9% saline solution
Group B will receive a 10μg Exenatide injection on Day 1 and placebo injection (0.9% saline solution) on Day 2.
Drug: Exenatide · Drug: 0.9% saline solution
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.
Drug: Exenatide
Day1: After a standardized night meal (Maizena 40g plus dessert) at 22 p.m. on the day before, patients receive Exenatide study medication according to the randomization list (injection done slowly over 2 min.). Regular clinical examination of vegetative and neurological state will be done as well as continuous blood sugar measurements and blood withdrawals will be performed. Day2: The procedure is equal to study day 1. Instead of Exenatide, a 10ml 0.9% saline solution will be administered intravenously.
Also known as: Day 1 Exenatide; Day 2 : 0.9% saline solution
Day1: After a standardized night meal (Maizena 40g plus dessert) at 22 p.m. on the day before, patients receive 0.9% saline solution according to the randomization list (injection done slowly over 2 min.). Regular clinical examination of vegetative and neurological state will be done as well as continuous blood sugar measurements and blood withdrawals will be performed. Day2: The procedure is equal to study day 1. Instead of 0.9% saline solution, Exenatide will be administered intravenously.
Also known as: Day 1 : 0.9% saline solution, Day 2 Exenatide
time to symptomatic hypoglycemia after exenatide test compared to placebo
time to symptomatic hypoglycemia after exenatide test compared to placebo
Time frame: within 4 hours after injection
time dependent decrease (time Δ from injection in min) of blood glucose (% or mmol/l))
time dependent decrease (time Δ from injection in min) of blood glucose (% or mmol/l)) that can best discriminate from placebo injection
Time frame: within 4 hours after injection
time to symptoms
time to symptoms of the exenatide test in comparison to the placebo injection of 10ml 0.9% saline solution
Time frame: within 4 hours after injection
time to hypoglycemia (time to reach blood sugar level ≤ 2.5 mmol/l) in the exenatide test in comparison to the placebo
time to hypoglycemia (time to reach blood sugar level ≤ 2.5 mmol/l) in the exenatide test in comparison to the placebo
Time frame: within 4 hours after injection
time to hypoglycemia (time to reach blood sugar level ≤ 2.5 mmol/l) in the exenatide test in comparison to the fasting test
time to hypoglycemia (time to reach blood sugar level ≤ 2.5 mmol/l) in the exenatide test in comparison to the fasting test
Time frame: within 4 hours after injection
time to symptoms in the exenatide test in comparison to the fasting test
time to symptoms in the exenatide test in comparison to the fasting test
Time frame: within 4 hours after injection
change in levels of plasma glucose compared to placebo compared to placebo
change in levels of plasma glucose compared to placebo
Time frame: within 4 hours after injection
change in levels of insulin compared to placebo
change in levels of insulin compared to placebo
Time frame: within 4 hours after injection
change in levels of C-peptide compared to placebo
change in levels of C-peptide compared to placebo compared to placebo
Time frame: within 4 hours after injection
change in levels of proinsulin compared to placebo
change in levels of proinsulin compared to placebo
Time frame: within 4 hours after injection
change in levels of ß-hydroxybutyrate compared to placebo
change in levels of ß-hydroxybutyrate compared to placebo
Time frame: within 4 hours after injection
costs of exenatide test setting (CHF)
Comparison of costs of exenatide test setting with fasting test setting
Time frame: within 4 hours after injection
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland →