Effects of glucagon on blood sugar levels in patients with post-bariatric hypoglycemia

Glucagon Dose-Response in Patients With Post-Bariatric Hypoglycemia

This study tests how different doses of glucagon can help people who have low blood sugar after weight loss surgery by looking at its effects on their blood sugar levels.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Joslin Diabetes Center (Academic / other)
• Drugs / interventions: radiation
• Locations: 2 sites (Birmingham, Alabama and 1 other locations)
• Trial ID: NCT06986603 on ClinicalTrials.gov

What this trial studies

This study investigates how different doses of glucagon affect blood sugar levels in individuals who have experienced hypoglycemia after bariatric surgery, specifically Roux-en-Y gastric bypass. Participants will undergo four visits to assess their health, including blood tests and continuous glucose monitoring. During the study, participants will receive varying doses of glucagon to evaluate its impact on glucose production and hormone regulation. The goal is to better understand glucagon sensitivity in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with ongoing post-bariatric hypoglycemia who have had Roux-en-Y gastric bypass for at least two years.

Not a fit: Patients with documented fasting hypoglycemia, current diabetes, or significant chronic health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for patients suffering from hypoglycemia after bariatric surgery.

How similar studies have performed: Other studies have explored glucagon's effects on blood sugar regulation, but this specific approach in post-bariatric hypoglycemia is relatively novel.

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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Where this trial is running

Birmingham, Alabama and 1 other locations

• University of Alabama — Birmingham, Alabama, United States (Recruiting)
• Joslin Diabetes Center — Boston, Massachusetts, United States (Recruiting)

Conditions Hypoglycemia; Hypoglycemia, Reactive; Bariatric Surgery; glucagon sensitivity