Glucagon Dose-Response in Patients With Post-Bariatric Hypoglycemia

NCTNCT06986603Other idSTUDY00000270Other idR01DK137518

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Overview

Status: Active, not recruiting
Phase: Phase 4
Enrollment: 28 participants (estimated)
Sponsor: Joslin Diabetes Center · Other
Design: Randomized · Single masking
Countries: 1 country
United States
Start: 26 Nov 2024
Primary completion: 1 Jun 2026 (estimated)
Completion: 1 Sept 2026 (estimated)
First posted: 23 May 2025
Last update posted: 6 Feb 2026
Conditions: Hypoglycemia · Hypoglycemia, Reactive · Bariatric Surgery

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2024202520262027

Ph 4
Glucagon Dose-Response in Patients With Post-Bariatric Hypoglycemia
NCT06986603
26 Nov 2024 to est. 1 Sept 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Glucagon for Injection (Fresenius Kabi USA)Drug

Arms2

Experimental
ascending doses of glucagon
Participants will receive sequential ascending doses of glucagon, 75, 150, 300, 450 micrograms during the course of the study visit.
Experimental
descending doses of glucagon
Participants will receive sequential descending doses of glucagon - 300, 150, 75 micrograms

Primary outcomes2

Outcomes the sponsor listed as primary.

Incremental change in plasma glucose levels after administration of exogenous glucagon for each dose.
Time frame · Measurement of glucose levels will occur at baseline, and then every 5 minutes, for 60 minutes.
Registry description
Glycemic response to exogenous glucagon for doses, as measured by incremental change in plasma glucose levels at each 30 minute step of the dose escalation protocol. AUC will be compared in each of the 2 study visits (escalation vs. deescalation).
Endogenous glucose production (EGP) after administration of exogenous glucagon.
Time frame · Measurement of glucose levels will occur at visit 2, at baseline, and then every 5 minutes after the first dose of glucagon, for 120 minutes
Registry description
Response to exogenous glucagon as measured by the incremental change in EGP from baseline during dose escalation or deescalation protocol.

Secondary outcomes(3)

Incremental change in plasma insulin levels during glucagon dose escalation protocol
Time frame · Measurement of insulin levels will occur at baseline, and then every 30 minutes after each dosetes.
Registry description
Insulin response to exogenous glucagon, as measured by incremental change in plasma insulin during dose escalation protocol
Insulin secretion rate in response to exogenous glucagon
Time frame · Measurement of insulin secretion rates will occur at visit 2, at baseline, and then 30 minutes after each dose of glucagon
Registry description
Insulin secretion rate in response to exogenous glucagon, as measured using the C-peptide model
Incremental change in GLP1 levels during glucagon dosing protocol
Time frame · Measurement will occur at visit 2, at baseline, and then every 30 minutes after each dose of glucagon
Registry description
GLP1 response to exogenous glucagon, as measured by incremental change in GLP1

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 70 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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: \-

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