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 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT01841359
Eligibility Criteria:
Inclusion Criteria:
* severe hypoglycemic episodes post-gastric bypass surgery
* normal fasting glucose
* age 21 to 65
* hypoglycemia must not have responded to dietary intervention (low glycemic index, controlled carbohydrate portions) and a trial of acarbose therapy at the maximally tolerated dose
Exclusion Criteria:
* Hypoglycemia in the fasting state (greater than 12 hours fast)
* History of preoperative diabetes mellitus
* Use of medications that affect gastrointestinal motility (e.g., cisapride, metoclopramide)
* Impaired renal function (creatinine clearance \< 20 ml/min or on dialysis
* Hepatic disease (defined as liver enzymes \> 2 times upper normal limit for alanine transaminase (ALT) and aspartate aminotransferase (AST))
* Blood donation for 2 months prior to the study.
* Severe hypoglycemic unawareness, as defined by inability to recognize adrenergic or neuroglycopenic symptoms of hypoglycemia despite detailed education
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT01841359
Study Brief:
Protocol Section:
NCT01841359