RECRUITING

Glucagon Dose-Response in Patients With Post-Bariatric Hypoglycemia

Conditions

Hypoglycemia Hypoglycemia, Reactive Bariatric Surgery glucagon sensitivity

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Glucagon Dose-Response in Patients With Post-Bariatric Hypoglycemia

Quick Facts

Study Start:2024-11-26

Study Completion:2026-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06986603

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Locations (Sites)

University of Alabama

Birmingham, Alabama, 35233

United States

Joslin Diabetes Center

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Joslin Diabetes Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-26

Study Completion Date2026-09-01

Study Record Updates

Study Start Date2024-11-26

Study Completion Date2026-09-01

Terms related to this study

Keywords Provided by Researchers

glucagon sensitivity

Additional Relevant MeSH Terms

Hypoglycemia
Hypoglycemia, Reactive
Bariatric Surgery