Glucagon Dose-Response in Patients With Post-Bariatric Hypoglycemia

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
University of Alabama
RECRUITING
Birmingham
Massachusetts
Joslin Diabetes Center
RECRUITING
Boston
Time Frame
Start Date: 2024-11-26
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 28
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Virginia, University of Alabama at Birmingham
Leads: Joslin Diabetes Center

This content was sourced from clinicaltrials.gov