Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT04909333
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04909333
Study Brief:
Protocol Section:
NCT04909333