Glucagon for Low Blood Sugar After Weight Loss Surgery

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Joslin Diabetes Center

Must not be taking: Diabetes medications, β-blockers, Corticosteroids

Disqualifiers: Diabetes, Chronic kidney disease, Hepatic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

28 Participants Needed

Trial Summary

What is the purpose of this trial?

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 Criteria

This trial is for individuals who have undergone bariatric surgery and are experiencing low blood sugar episodes (post-bariatric hypoglycemia). Participants should be in good general health, based on medical history, physical exam, and blood tests. Specific eligibility criteria were not provided.

Inclusion Criteria

Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits

I have had low blood sugar episodes after gastric bypass surgery 2 years ago.

Exclusion Criteria

Documented hypoglycemia occurring only in the fasting state (>12 hours fast)

I have diabetes with an A1c over 6.5% or I'm on diabetes medication (not acarbose or miglitol).

I have been diagnosed with moderate to severe heart failure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 hours

1 visit (in-person)

CGM Placement

Placement of a continuous glucose monitor to track glucose levels

1 hour

1 visit (in-person)

Treatment - Glucagon Dose Escalation

Participants receive ascending doses of glucagon to assess blood sugar response

5 hours

1 visit (in-person)

Treatment - Glucagon Dose De-escalation (Optional)

Participants receive descending doses of glucagon to assess blood sugar response

5 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• Glucagon

Trial Overview The study is testing how different doses of injected glucagon affect blood sugar levels in patients with post-bariatric hypoglycemia. It involves four visits: initial assessment, glucose monitor placement, and two sessions where increasing and decreasing doses of glucagon are administered.

Participant Groups

Group I: descending doses of glucagon Experimental Treatment 1 Intervention

Participants will receive sequential descending doses of glucagon - 300, 150, 75 micrograms

Group II: ascending doses of glucagon Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Joslin Diabetes Center

Lead Sponsor

Trials

98

Recruited

26,500+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+