Glucagon Dose-Response in Patients With Post-Bariatric Hypoglycemia

Launched by JOSLIN DIABETES CENTER · May 15, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how different doses of glucagon, a hormone that helps control blood sugar levels, affect people who experience low blood sugar (hypoglycemia) after having weight-loss surgery called bariatric surgery. The study aims to see how both individuals with and without hypoglycemia respond to glucagon. To participate, you must be between 18 and 70 years old, have had Roux-en-Y gastric bypass surgery at least two years ago, and have a history of low blood sugar episodes.

If you join the study, you will make four visits to the research center. During the first visit, doctors will take your medical history, do a physical exam, and collect some blood samples. In the second visit, a small device will be placed under your skin to monitor your blood sugar continuously. The third and fourth visits will involve testing how your body reacts to different doses of glucagon. You will also have glucose infused to help measure how your body produces sugar and other hormones involved in blood sugar regulation. It's essential to be available for all visits and be willing to follow the study procedures.

Gender

ALL

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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