Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia

What Was Tested

In this not phased trial, researchers set out to test Exenatide.

It had three arms (groups): Group A (EHH Patients) (experimental), Group B (EHH Patients) (experimental) and Group C (control subjects) (experimental).

The registry classes the interventions as drug.

More on the Plan

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.

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.

Who Took Part

The registry lists 29 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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).). 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.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: known hypersensitivity or allergy to exenatide; pregnant or breastfeeding female patients. a pregnancy test will be performed in all women of child bearing potential; no signed informed consent.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

Each person switched between Exenatide and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on Exenatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2021-04-29 with completion listed for 2024-04-30.

It ran at 1 site in Switzerland.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: time to symptomatic hypoglycemia after exenatide test compared to placebo (time frame: within 4 hours after injection).

It also tracked 11 secondary outcomes, for example time to symptoms, time to symptoms in the exenatide test in comparison to the fasting test, change in levels of insulin compared to placebo, change in levels of C-peptide compared to placebo, change in levels of proinsulin compared to placebo and change in levels of ß-hydroxybutyrate compared to placebo.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Exenatide in 29 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, all human trials.