Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia
Switzerland29 participantsStarted 2021-04-29
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 contr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
time to symptomatic hypoglycemia after exenatide test compared to placebo