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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different doses of glucagon, a natural hormone that controls blood sugar, can manage low blood sugar in individuals who have undergone weight loss surgery. The focus is on those who have experienced hypoglycemia (dangerously low blood sugar) at least two years after Roux-en-Y gastric bypass surgery. Participants will receive varying doses of glucagon to observe their blood sugar level responses. This trial suits individuals with documented episodes of low blood sugar after weight loss surgery. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, offering participants the chance to contribute to research that helps understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking certain medications like diabetes drugs (except acarbose or miglitol), β-blockers, long-acting octreotide or pasireotide, or corticosteroids.

What is the safety track record for glucagon?

Research shows that glucagon, the hormone studied in this trial, naturally occurs in the body and helps control blood sugar levels. It often treats certain types of low blood sugar and is generally considered safe. In this study, participants will receive varying amounts of glucagon.

Previous studies have shown that most people tolerate glucagon well, with few side effects reported. Some might experience mild side effects like nausea or discomfort at the injection site. However, serious side effects are rare. As this study is in a later stage, substantial evidence supports its safety, indicating it has been tested in many people before and found to be generally safe. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about glucagon as a treatment for low blood sugar after weight loss surgery because it offers a new approach compared to standard treatments like dextrose or carbohydrate intake. Glucagon works by stimulating the liver to release glucose, which can raise blood sugar levels quickly. This mechanism is different from typical oral intake methods, providing a potentially faster and more efficient way to address hypoglycemia. Additionally, the trial is exploring both ascending and descending doses, which could help tailor the treatment to individual needs and optimize its effectiveness.

What evidence suggests that glucagon might be an effective treatment for low blood sugar after weight loss surgery?

Research has shown that glucagon can help manage low blood sugar after weight loss surgery. In this trial, participants will receive either ascending or descending doses of glucagon to evaluate its effectiveness. One study found that dasiglucagon, a type of glucagon, significantly reduced low blood sugar episodes in patients. This suggests glucagon can help maintain steady blood sugar levels. Up to one-third of patients who undergo weight loss surgery experience low blood sugar, and treatments like glucagon may provide relief. By raising blood sugar levels, glucagon offers a promising option for managing drops in blood sugar after surgery. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK592417/

Postbariatric Surgery Hypoglycemia - StatPearls - NCBI - NIH

A recent retrospective observational study of patients with post-bariatric surgery hypoglycemia reported on outcomes of patients who had failed ...

2.

ccjm.org

ccjm.org/content/92/2/103

Hypoglycemia after bariatric surgery: Management updates

Up to one-third of patients who underwent bariatric surgery reported symptoms of hypoglycemia during mixed meal challenges, while oral glucose ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2451847624000034

Glucagon-like peptide-1 receptor agonists for post-bariatric ...

Limited data suggest that GLP1-RA might also be beneficial in managing post-bariatric surgery hypoglycemia, offering dual benefits (Abrahamsson et al., 2013).

4.

diabetesjournals.org

diabetesjournals.org/care/article/46/12/2208/153719/Dasiglucagon-Treatment-for-Postprandial

Dasiglucagon Treatment for Postprandial Hypoglycemia After ...

Compared with placebo, 4 weeks of self-administered dasiglucagon effectively reduced clinically relevant hypoglycemia in individuals who had ...

5.

dmsjournal.biomedcentral.com

dmsjournal.biomedcentral.com/articles/10.1186/s13098-025-01988-y

Managing post-bariatric hypoglycemia: a systematic review of ...

Acarbose improves hypoglycaemia following gastric bypass surgery without increasing glucagon-like peptide 1 levels. Obes Surg. 2012;22(4): ...

6.

nmcd-journal.com

nmcd-journal.com/article/S0939-4753(23)00070-4/fulltext

Persistent post-bariatric-surgery hypoglycemia: A long-term ...

During MTT, hypoglycemia occurred in 3/4 (18/24) of the patients and a third of them (33%) developed severe hypoglycemia. These findings were ...

7.

gastrojournal.org

gastrojournal.org/article/S0016-5085(14)00097-3/fulltext

Hypoglycemia After Gastric Bypass: The Dark Side of GLP-1

More severe hypoglycemia associated with neuroglycopenia, loss of consciousness, seizures, and motor vehicle accidents, is rare but typically occurs 1–3 years ...

8.

amylyx.com

amylyx.com/post-bariatric-hypoglycemia

Post-Bariatric Hypoglycemia (PBH)

Avexitide has demonstrated highly statistically significant and clinically meaningful data with a well-tolerated safety profile across multiple clinical trials, ...