Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-30 @ 2:55 PM
Study NCT ID:
NCT04909333
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2021-05-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'C565100', 'term': 'Diabetes Mellitus, Insulin-Dependent, 2'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077270', 'term': 'Exenatide'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014688', 'term': 'Venoms'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Prospective, single-center, cross-over, placebo controlled pilot, proof of principle clinical study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2021-05-26', 'studyFirstSubmitQcDate': '2021-05-26', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to symptomatic hypoglycemia after exenatide test compared to placebo', 'timeFrame': 'within 4 hours after injection', 'description': 'time to symptomatic hypoglycemia after exenatide test compared to placebo'}], 'secondaryOutcomes': [{'measure': 'time dependent decrease (time Δ from injection in min) of blood glucose (% or mmol/l))', 'timeFrame': 'within 4 hours after injection', 'description': 'time dependent decrease (time Δ from injection in min) of blood glucose (% or mmol/l)) that can best discriminate from placebo injection'}, {'measure': 'time to symptoms', 'timeFrame': 'within 4 hours after injection', 'description': 'time to symptoms of the exenatide test in comparison to the placebo injection of 10ml 0.9% saline solution'}, {'measure': 'time to hypoglycemia (time to reach blood sugar level ≤ 2.5 mmol/l) in the exenatide test in comparison to the placebo', 'timeFrame': 'within 4 hours after injection', 'description': 'time to hypoglycemia (time to reach blood sugar level ≤ 2.5 mmol/l) in the exenatide test in comparison to the placebo'}, {'measure': 'time to hypoglycemia (time to reach blood sugar level ≤ 2.5 mmol/l) in the exenatide test in comparison to the fasting test', 'timeFrame': 'within 4 hours after injection', 'description': 'time to hypoglycemia (time to reach blood sugar level ≤ 2.5 mmol/l) in the exenatide test in comparison to the fasting test'}, {'measure': 'time to symptoms in the exenatide test in comparison to the fasting test', 'timeFrame': 'within 4 hours after injection', 'description': 'time to symptoms in the exenatide test in comparison to the fasting test'}, {'measure': 'change in levels of plasma glucose compared to placebo compared to placebo', 'timeFrame': 'within 4 hours after injection', 'description': 'change in levels of plasma glucose compared to placebo'}, {'measure': 'change in levels of insulin compared to placebo', 'timeFrame': 'within 4 hours after injection', 'description': 'change in levels of insulin compared to placebo'}, {'measure': 'change in levels of C-peptide compared to placebo', 'timeFrame': 'within 4 hours after injection', 'description': 'change in levels of C-peptide compared to placebo compared to placebo'}, {'measure': 'change in levels of proinsulin compared to placebo', 'timeFrame': 'within 4 hours after injection', 'description': 'change in levels of proinsulin compared to placebo'}, {'measure': 'change in levels of ß-hydroxybutyrate compared to placebo', 'timeFrame': 'within 4 hours after injection', 'description': 'change in levels of ß-hydroxybutyrate compared to placebo'}, {'measure': 'costs of exenatide test setting (CHF)', 'timeFrame': 'within 4 hours after injection', 'description': 'Comparison of costs of exenatide test setting with fasting test setting'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fasting test', 'Blood glucose', 'insulin', 'proinsulin', 'C-peptide', 'betahydroxybutyrate', 'hypoglycemia'], 'conditions': ['Endogenous Hyperinsulinism']}, 'referencesModule': {'references': [{'pmid': '40747712', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nRadiolabeled 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.\n\nThis study is to investigate the concept of the exenatide test to diagnose EHH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Patients with suspicion for an insulinoma fulfilling all of the following inclusion criteria are eligible for the study:\n\nInclusion Criteria:\n\n* Informed Consent as documented by signature\n* 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).).\n\nParticipants as control subjects fulfilling all of the following inclusion criteria are eligible for the study:\n\nInclusion Criteria:\n\n* Informed Consent as documented by signature (Appendix Informed Consent Form)\n* Possession of the adequate match criteria (age, BMI and gender) to patients with suspicion for an insulinoma\n\nExclusion Criteria:\n\n* Known hypersensitivity or allergy to Exenatide\n* Pregnant or breastfeeding female patients. A pregnancy test will be performed in all women of child bearing potential.\n* Calculated creatinine clearance below 40 ml/min\n* No signed informed consent\n* Intake of any glucagon-like peptide (GLP)-1 analogue (such as Byetta® or Bydureon®\\[= Exenatide\\])\n* prediabetes or diabetes (HbA1c \\> 5.7 %)\n* Previous abdominal surgery in the gastrointestinal tract\n* Any concomitant glucose-lowering drug (i. e. insulin, sulfonyl urea)\n* Any known intolerance to standardized meal (Maizena)\n* 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.\n* 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"}, 'identificationModule': {'nctId': 'NCT04909333', 'acronym': 'FAST', 'briefTitle': 'Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia', 'orgStudyIdInfo': {'id': '2020-00169; qu20Antwi2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (EHH Patients)', 'description': 'Group A will receive a placebo injection (0.9% saline solution) on Day 1 and 10μg Exenatide injection on Day 2.', 'interventionNames': ['Drug: Exenatide', 'Drug: 0.9% saline solution']}, {'type': 'EXPERIMENTAL', 'label': 'Group B (EHH Patients)', 'description': 'Group B will receive a 10μg Exenatide injection on Day 1 and placebo injection (0.9% saline solution) on Day 2.', 'interventionNames': ['Drug: Exenatide', 'Drug: 0.9% saline solution']}, {'type': 'EXPERIMENTAL', 'label': 'Group C (control subjects)', 'description': '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.', 'interventionNames': ['Drug: Exenatide']}], 'interventions': [{'name': 'Exenatide', 'type': 'DRUG', 'otherNames': ['Day 1 Exenatide; Day 2 : 0.9% saline solution'], 'description': '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.\n\nDay2:\n\nThe procedure is equal to study day 1. Instead of Exenatide, a 10ml 0.9% saline solution will be administered intravenously.', 'armGroupLabels': ['Group A (EHH Patients)', 'Group B (EHH Patients)', 'Group C (control subjects)']}, {'name': '0.9% saline solution', 'type': 'DRUG', 'otherNames': ['Day 1 : 0.9% saline solution, Day 2 Exenatide'], 'description': '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.\n\nDay2:\n\nThe procedure is equal to study day 1. Instead of 0.9% saline solution, Exenatide will be administered intravenously.', 'armGroupLabels': ['Group A (EHH Patients)', 'Group B (EHH Patients)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital Basel, Division of Nuclear Medicine', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Emanuel Christ, Prof. Dr. med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital of Basel, Interdisciplinary Endocrinology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}