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NCT04909333·Not applicable·INTERVENTIONAL

Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia

ExenatideOtherCompleted

Status

Completed

Phase

Not applicable

Enrollment

29

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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).

Full 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-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.

Interventions

Treatment arms and agents.

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.

DRUG

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.

Timeline

From registration to results.

  1. First posted

    Jun 1, 2021

  2. Study start

    Apr 29, 2021

  3. Primary completion

    Apr 30, 2024

  4. Study completion

    Apr 30, 2024

  5. Results posted

    Not reported

  6. Registry updated

    May 8, 2024

Outcomes

What the study measures.

Primary outcomes

time to symptomatic hypoglycemia after exenatide test compared to placebo

Time frame · within 4 hours after injection

time to symptomatic hypoglycemia after exenatide test compared to placebo

Secondary outcomes

time dependent decrease (time Δ from injection in min) of blood glucose (% or mmol/l))

Time frame · within 4 hours after injection

time dependent decrease (time Δ from injection in min) of blood glucose (% or mmol/l)) that can best discriminate from placebo injection

time to symptoms

Time frame · within 4 hours after injection

time to symptoms of the exenatide test in comparison to the placebo injection of 10ml 0.9% saline solution

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 placebo

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 hypoglycemia (time to reach blood sugar level ≤ 2.5 mmol/l) 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

time to symptoms in the exenatide test in comparison to the fasting test

change in levels of plasma glucose compared to placebo compared to placebo

Time frame · within 4 hours after injection

change in levels of plasma glucose compared to placebo

change in levels of insulin compared to placebo

Time frame · within 4 hours after injection

change in levels of insulin compared to placebo

change in levels of C-peptide compared to placebo

Time frame · within 4 hours after injection

change in levels of C-peptide compared to placebo compared to placebo

change in levels of proinsulin compared to placebo

Time frame · within 4 hours after injection

change in levels of proinsulin compared to placebo

change in levels of ß-hydroxybutyrate compared to placebo

Time frame · within 4 hours after injection

change in levels of ß-hydroxybutyrate compared to placebo

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 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

Study locations

1 registered sites.

Switzerland. Showing up to 24 locations stored in the fast local snapshot.

University Hospital Basel, Division of Nuclear Medicine

Basel, Switzerland

Publications

Results and literature.

PMID 40747712 ↗Hepprich M, Romberg C, Mudry J, Refardt J, Wild D, Antwi K, Christ E. Exenatide for diagnosing endogenous hyperinsulinemic hypoglycemia: a randomized placebo-controlled, double-blind, cross-over proof-of-principle study. Eur J Endocrinol. 2025 Jul 31;193(2):247-254. doi: 10.1093/ejendo/lvaf153.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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