Clinical trial

Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia

Name

2020-00169; qu20Antwi2

Description

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).

Trial arms

Trial start

2021-04-29

Estimated PCD

2024-04-30

Trial end

2024-04-30

Status

Completed

Treatment

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.

Arms:

Group A (EHH Patients), Group B (EHH Patients), Group C (control subjects)

Other names:

Day 1 Exenatide; Day 2 : 0.9% saline solution

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.

Arms:

Group A (EHH Patients), Group B (EHH Patients)

Other names:

Day 1 : 0.9% saline solution, Day 2 Exenatide

Size

Primary endpoint

time to symptomatic hypoglycemia after exenatide test compared to placebo

within 4 hours after injection

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Prospective, single-center, cross-over, placebo controlled pilot, proof of principle clinical study', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 29, 'type': 'ACTUAL'}}

Updated at

2024-05-08

1 organization

1 product

1 drug

1 indication

Organization

University Hospital Basel

Product

Exenatide

Indication

Hyperinsulinemia

Drug

Varlilumab