Back to resultsExenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia (FAST)
Primary Purpose
Endogenous Hyperinsulinism
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Exenatide
0.9% saline solution
Sponsored by
About this trial
This is an interventional basic science trial for Endogenous Hyperinsulinism focused on measuring fasting test, Blood glucose, insulin, proinsulin, C-peptide, betahydroxybutyrate, hypoglycemia
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
Sites / Locations
- University Hospital Basel, Division of Nuclear MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group A (EHH Patients)
Group B (EHH Patients)
Group C (control subjects)
Arm Description
Group A will receive a placebo injection (0.9% saline solution) on Day 1 and 10μg Exenatide injection on Day 2.
Group B will receive a 10μg Exenatide injection on Day 1 and placebo injection (0.9% saline solution) on Day 2.
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.
Outcomes
Primary Outcome Measures
time to symptomatic hypoglycemia after exenatide test compared to placebo
time to symptomatic hypoglycemia after exenatide test compared to placebo
Secondary Outcome Measures
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 to symptoms
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 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 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 to symptoms in the exenatide test in comparison to the fasting test
change in levels of plasma glucose compared to placebo compared to placebo
change in levels of plasma glucose compared to placebo
change in levels of insulin compared to placebo
change in levels of insulin compared to placebo
change in levels of C-peptide compared to placebo
change in levels of C-peptide compared to placebo compared to placebo
change in levels of proinsulin compared to placebo
change in levels of proinsulin compared to placebo
change in levels of ß-hydroxybutyrate compared to placebo
change in levels of ß-hydroxybutyrate compared to placebo
costs of exenatide test setting (CHF)
Comparison of costs of exenatide test setting with fasting test setting
Full Information
NCT ID
NCT04909333
First Posted
May 26, 2021
Last Updated
July 26, 2023
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Gottfried und Julia Bangerter-Rhyner-Stiftung
1. Study Identification
Unique Protocol Identification Number
NCT04909333
Brief Title
Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia
Acronym
FAST
Official Title
Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 29, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Gottfried und Julia Bangerter-Rhyner-Stiftung
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endogenous Hyperinsulinism
Keywords
fasting test, Blood glucose, insulin, proinsulin, C-peptide, betahydroxybutyrate, hypoglycemia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Prospective, single-center, cross-over, placebo controlled pilot, proof of principle clinical study
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A (EHH Patients)
Arm Type
Experimental
Arm Description
Group A will receive a placebo injection (0.9% saline solution) on Day 1 and 10μg Exenatide injection on Day 2.
Arm Title
Group B (EHH Patients)
Arm Type
Experimental
Arm Description
Group B will receive a 10μg Exenatide injection on Day 1 and placebo injection (0.9% saline solution) on Day 2.
Arm Title
Group C (control subjects)
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Exenatide
Other Intervention Name(s)
Day 1 Exenatide; Day 2 : 0.9% saline solution
Intervention 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.
Day2:
The procedure is equal to study day 1. Instead of Exenatide, a 10ml 0.9% saline solution will be administered intravenously.
Intervention Type
Drug
Intervention Name(s)
0.9% saline solution
Other Intervention Name(s)
Day 1 : 0.9% saline solution, Day 2 Exenatide
Intervention 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.
Day2:
The procedure is equal to study day 1. Instead of 0.9% saline solution, Exenatide will be administered intravenously.
Primary Outcome Measure Information:
Title
time to symptomatic hypoglycemia after exenatide test compared to placebo
Description
time to symptomatic hypoglycemia after exenatide test compared to placebo
Time Frame
within 4 hours after injection
Secondary Outcome Measure Information:
Title
time dependent decrease (time Δ from injection in min) of blood glucose (% or mmol/l))
Description
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
Title
time to symptoms
Description
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
Title
time to hypoglycemia (time to reach blood sugar level ≤ 2.5 mmol/l) in the exenatide test in comparison to the placebo
Description
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
Title
time to hypoglycemia (time to reach blood sugar level ≤ 2.5 mmol/l) in the exenatide test in comparison to the fasting test
Description
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
Title
time to symptoms in the exenatide test in comparison to the fasting test
Description
time to symptoms in the exenatide test in comparison to the fasting test
Time Frame
within 4 hours after injection
Title
change in levels of plasma glucose compared to placebo compared to placebo
Description
change in levels of plasma glucose compared to placebo
Time Frame
within 4 hours after injection
Title
change in levels of insulin compared to placebo
Description
change in levels of insulin compared to placebo
Time Frame
within 4 hours after injection
Title
change in levels of C-peptide compared to placebo
Description
change in levels of C-peptide compared to placebo compared to placebo
Time Frame
within 4 hours after injection
Title
change in levels of proinsulin compared to placebo
Description
change in levels of proinsulin compared to placebo
Time Frame
within 4 hours after injection
Title
change in levels of ß-hydroxybutyrate compared to placebo
Description
change in levels of ß-hydroxybutyrate compared to placebo
Time Frame
within 4 hours after injection
Title
costs of exenatide test setting (CHF)
Description
Comparison of costs of exenatide test setting with fasting test setting
Time Frame
within 4 hours after injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kwadwo Antwi, Dr. med.
Phone
+ 41 61 685 85 85
Email
Kwadwo.Antwi@claraspital.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Matthias Hepprich, Dr. med.
Phone
+41 76 277 90 54
Email
Matthias.Hepprich@usb.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emanuel Christ, Prof. Dr. med.
Organizational Affiliation
University Hospital of Basel, Interdisciplinary Endocrinology
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Basel, Division of Nuclear Medicine
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwadwo Antwi, Dr. med.
Phone
+ 41 61 685 85 85
Email
Kwadwo.Antwi@claraspital.ch
First Name & Middle Initial & Last Name & Degree
Kwadwo Antwi, Dr. med.
First Name & Middle Initial & Last Name & Degree
Matthias Hepprich, Dr. med.
First Name & Middle Initial & Last Name & Degree
Damian Wild, Prof. Dr. med.
First Name & Middle Initial & Last Name & Degree
Felix Kaul, Dr. med.
First Name & Middle Initial & Last Name & Degree
Tobias Heye, Dr. med.
First Name & Middle Initial & Last Name & Degree
Emanuel Christ, Prof. Dr. med.
First Name & Middle Initial & Last Name & Degree
Jonathan Mudry, Dr. med
First Name & Middle Initial & Last Name & Degree
Martin Freitag, PD Dr. med.
12. IPD Sharing Statement
Learn more about this trial
Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia
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