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Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia
Not Recruiting
Trial ID: NCT03373435
Purpose
This clinical study will evaluate whether taking an investigational drug called exendin 9-39
is safe, well-tolerated, and helps to prevent low blood sugar in people who have had
bariatric surgery and later develop a rare condition called postbariatric hypoglycemia (PBH).
Official Title
A Phase 2, Multicenter, Randomized, Single-Blind, Placebo-Controlled Cross-over Study to Assess the Efficacy and Safety of Exendin 9-39 in Patients With Postbariatric Hypoglycemia
Stanford Investigator(s)
Marilyn Tan
Clinical Associate Professor, Medicine - Endocrinology, Gerontology, & Metabolism
Eligibility
Inclusion Criteria:
- Body mass index (BMI) of up to 40 kg/m2
- Roux-en-Y gastric bypass (RYGB) surgery performed ≥12 months prior
- Diagnosis of PBH
- At least 2 episodes during screening 2-week run-in phase of severe hypoglycemia
Exclusion Criteria:
- Other cause of endogenous hyperinsulinism other than PBH
- Metabolic or bariatric surgical procedure other than RYGB
- History of non-RYGB upper GI surgery
- Use of agents that may interfere with glucose metabolism
Intervention(s):
drug: exendin 9-39
other: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Aileen Muno
(650) 725-9890