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:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT06986603
Eligibility Criteria:
Inclusion criteria:
1. Age 18-70 years of age, inclusive, at screening.
2. Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.
3. Males or females diagnosed with ongoing PBH, at least 2 years following Roux-en-Y gastric bypass (RYGB), with documented episodes of hypoglycemia, and history of fulfillment of Whipple's triad.
Exclusion criteria:
1. Documented hypoglycemia occurring only in the fasting state (\>12 hours fast);
2. Current diabetes, defined as hemoglobin A1c \>6.5% or use of diabetes medications, except for acarbose or miglitol;
3. Chronic kidney disease stage 4 or 5 (including end-stage renal disease);
4. Hepatic disease, including serum ALT or AST greater than 2 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin \< 3.0 g/dL; or serum bilirubin \> 2.0;
5. Congestive heart failure, NYHA class II, III or IV;
6. History of myocardial infarction, unstable angina or revascularization within the past 6 months.
7. Two or more risk factors for coronary artery disease including diabetes, uncontrolled hypertension, uncontrolled hyperlipidemia, and active tobacco use.
8. History of recurrent syncope (unrelated to hypoglycemia) or active diagnosis of a cardiac arrhythmia;
9. Current administration of β-blocker therapy;
10. History of a cerebrovascular accident;
11. Seizure disorder (other than with suspect or documented hypoglycemia);
12. Active treatment with long-acting (LAR) octreotide or pasireotide;
13. Active malignancy, except basal cell or squamous cell skin cancers;
14. Personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease);
15. Known insulinoma;
16. Major surgical operation within 30 days prior to screening;
17. Clinically significant anemia as defined as a hematocrit \< 33%;
18. Bleeding disorder, treatment with warfarin, or platelet count \<50,000;
19. Blood donation (1 pint of whole blood) within the past 2 months;
20. Active alcohol abuse or substance abuse;
21. Current administration of oral or parenteral corticosteroids;
22. Pregnancy and/ or lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test before any procedures.
23. Not enrolled in another study that uses an investigational drug for this condition.
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Exclusion Criteria:
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06986603
Study Brief:
Protocol Section:
NCT06986603