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 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT02527993
Eligibility Criteria:
Inclusion Criteria:
* symptoms of postprandial hyperinsulinemic hypoglycemia.
* fluctuations in blood glucose of more than 5 mmol/L during daily living
* at least one blood glucose reading below 3.5 mmol/L.
* More than 18 months since RYGB
* HbA1c \< 40 mmol/L
* Hemoglobin \> 7,3 mmol/L
* Ferritin \> 30 µg/L
* Cobalamin \> 150 picomol/L
* Creatinine \< 105 mmol/L
* C peptide \> 1,0 nmol/L
* Insulin \> 35 pmol/L
* Normal EKG
* Negative human chorionic gonadotropin (hCG) urine test
* Females of reproductive age: use of safe contraception
Exclusion Criteria:
* Treatment for cardiovascular disease
* Treatment with antipsychotics, antidepressants or anxiolytics
* Smoking
* Treatment for thyroid disease
* Prior medical treatment of postprandial hyperinsulinemic hypoglycemia
* Allergy for the study medicine
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
25 Years
Maximum Age:
60 Years
Study:
NCT02527993
Study Brief:
Protocol Section:
NCT02527993