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ACTIVE NOT RECRUITING

NCT06986603

PHASE4

Glucagon Dose-Response in Patients With Post-Bariatric Hypoglycemia

Sponsor: Joslin Diabetes Center

View on ClinicalTrials.gov

Summary

The purpose of the study is to determine how blood sugar levels in individuals with and without hypoglycemia after bariatric surgery respond to different doses of glucagon, a hormone that is usually present in your body that regulates blood sugar levels. In this study, there will be 4 visits to the clinical research center. In the first visit, medical history and physical exam will be performed, and blood samples will be taken to assess overall health. During visit 2, a continuous glucose monitor will be placed under the skin. (This may be combined with visit 1, depending on the schedule of visits.) In visit 3, we will test the effect of a total of 4 different doses of glucagon, in increasing doses. In visit 4, we will test the effect of a total of 3 doses of glucagon, in decreasing doses. For both visit 3 and 4, we will infuse labeled stable glucose to allow us to measure how much glucose the body is making, and will measure levels of hormones which regulate glucose, such as insulin and glucagon.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-11-26

Completion Date

2026-09-01

Last Updated

2026-02-06

Healthy Volunteers

Conditions

Hypoglycemia Hypoglycemia, Reactive Bariatric Surgery

Interventions

DRUG

Glucagon for Injection (Fresenius Kabi USA)

We are assessing response to glucose, including incremental glucose values as well as changes in endogenous glucose production, insulin secretion, and glucagon levels.

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. \- Exclusion Criteria: \-

Locations (2)

University of Alabama

Birmingham, Alabama, United States

Joslin Diabetes Center

Boston, Massachusetts, United States