Status:
RECRUITING
Glucagon Dose-Response in Patients With Post-Bariatric Hypoglycemia
Lead Sponsor:
Joslin Diabetes Center
Collaborating Sponsors:
University of Alabama at Birmingham
University of Virginia
Conditions:
Hypoglycemia
Hypoglycemia, Reactive
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 p...
Detailed Description
Visit 1 (Screening) This visit will last about 2 hours. You will be instructed to come to Joslin Diabetes Center after fasting for at least 8 hours (nothing but water for eight hours before your visi...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age 18-70 years of age, inclusive, at screening.
- Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.
- 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:
- Documented hypoglycemia occurring only in the fasting state (\>12 hours fast);
- Current diabetes, defined as hemoglobin A1c \>6.5% or use of diabetes medications, except for acarbose or miglitol;
- Chronic kidney disease stage 4 or 5 (including end-stage renal disease);
- 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;
- Congestive heart failure, NYHA class II, III or IV;
- History of myocardial infarction, unstable angina or revascularization within the past 6 months.
- Two or more risk factors for coronary artery disease including diabetes, uncontrolled hypertension, uncontrolled hyperlipidemia, and active tobacco use.
- History of recurrent syncope (unrelated to hypoglycemia) or active diagnosis of a cardiac arrhythmia;
- Current administration of β-blocker therapy;
- History of a cerebrovascular accident;
- Seizure disorder (other than with suspect or documented hypoglycemia);
- Active treatment with long-acting (LAR) octreotide or pasireotide;
- Active malignancy, except basal cell or squamous cell skin cancers;
- Personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease);
- Known insulinoma;
- Major surgical operation within 30 days prior to screening;
- Clinically significant anemia as defined as a hematocrit \< 33%;
- Bleeding disorder, treatment with warfarin, or platelet count \<50,000;
- Blood donation (1 pint of whole blood) within the past 2 months;
- Active alcohol abuse or substance abuse;
- Current administration of oral or parenteral corticosteroids;
- Pregnancy and/ or lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test before any procedures.
- Not enrolled in another study that uses an investigational drug for this condition.
- \-
- Exclusion Criteria:
- \-
Exclusion
Key Trial Info
Start Date :
November 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06986603
Start Date
November 26 2024
End Date
September 1 2026
Last Update
May 30 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama
Birmingham, Alabama, United States, 35233
2
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215