NCT04909333Completed
Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia
Source: ClinicalTrials.gov · Last updated 8 May 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 29 (actual)
- First submitted
- 26 May 2021
- Start date
- 29 Apr 2021
- Primary completion date
- 30 Apr 2024
- Lead sponsor
- University Hospital, Basel, Switzerland
- NCT number
- NCT04909333
What you commit to
- Study type: Interventional
- Participants enrolled: 29
- From 29 Apr 2021 to the primary completion date, 30 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous abdominal surgery in the gastrointestinal tract
Other illness
- Known hypersensitivity or allergy to Exenatide
- 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
Lab values
- Calculated creatinine clearance below 40 ml/min
- prediabetes or diabetes (HbA1c \> 5.7 %)
- Any concomitant glucose-lowering drug (i. e. insulin, sulfonyl urea)
- 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.
Other
- Pregnant or breastfeeding female patients. A pregnancy test will be performed in all women of child bearing potential.
- No signed informed consent
- Intake of any glucagon-like peptide (GLP)-1 analogue (such as Byetta® or Bydureon®\[= Exenatide\])
- Any known intolerance to standardized meal (Maizena)
Who the study is looking for
- 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:
- 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
Criteria the registry did not label
- Patients with suspicion for an insulinoma fulfilling all of the following inclusion criteria are eligible for the study:
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Basel, Division of Nuclear Medicine Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.