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:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
NCT ID:
NCT07029412
Eligibility Criteria:
Inclusion Criteria:
1. Participant must be ≥18 to ≤75 years of age at the time of signing the informed consent.
2. Participants must have undergone RYGB or SG surgery at least 12 months prior to study entry.
3. Participants should have a documented history of PBH, defined as Whipple's triad (symptomatic hypoglycemia, capillary glucose ≤54 mg/dL, with symptom resolution by carbohydrate administration) and a minimum of 1 symptomatic hypoglycemic episode per month by patient report.
4. Participants who are either treatment naïve or who are no longer using (i.e., have discontinued as part of their usual medical care) agents known to interfere with glucose metabolism at the time of screening.
5. Participants must have a body mass index (BMI) \<45 kg/m2 at screening.
6. Must have signed informed consent.
Exclusion Criteria:
1. History of, or currently active, significant illness or medical disorders that in the opinion of the investigator may preclude participants from participating in the study.
2. Currently on-going type II diabetes mellitus.
3. History of hypoglycemia prior to bariatric surgery.
4. History of insulinoma or other endogenous hyperinsulinemia illness (e.g., congenital hyperinsulinism).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07029412
Study Brief:
Protocol Section:
NCT07029412