40 Participants NeededMy employer runs this trial

Glucagon for Low Blood Sugar After Bariatric Surgery

Recruiting at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Joslin Diabetes Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

In this study, the investigators will determine (a) whether metabolism (secretion and turnover) of glucagon is altered in patients with PBH, (b) whether this is affected by a meal, (c) whether PBH affects the ability of the body to produce glucose (endogenous glucose production), and (d) whether PBH affects the amount of glycogen in the liver (storage form of glucose) when fasting and after a meal. The investigators will determine the effect of glucagon to raise glucose levels after a meal. To answer these questions, participants will receive an infusion of a stable (nonradioactive) isotope of glucose and glucagon, and a meal containing a stable isotope of glucose. Glycogen will be measured by magnetic resonance imaging (MRI) of the liver before and after the meal. This information will be used to develop computer models for the glucagon pump system.

Who Is on the Research Team?

AB

Ananda Basu, MD

Principal Investigator

University of Alabama at Birmingham

MP

Mary-Elizabeth Patti, MD

Principal Investigator

Joslin Diabetes Center

Are You a Good Fit for This Trial?

This trial is for adults who have had gastric bypass surgery, with or without experiencing low blood sugar after meals (post-bariatric hypoglycemia). Participants should not have other major health issues that could interfere with the study.

Inclusion Criteria

I have ongoing PBH with documented low blood sugar and meet Whipple's triad criteria.
Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits
I had Roux-en-Y gastric bypass surgery over 2 years ago.
See 1 more

Exclusion Criteria

Blood donation (1 pint of whole blood) within the past 2 months
I have a seizure disorder not caused by low blood sugar.
I am currently taking long-acting octreotide or pasireotide.
See 20 more

What Are the Treatments Tested in This Trial?

Interventions

  • Glucagon for Injection

Trial Overview

Researchers are studying how the body processes glucose and glucagon after a meal in people with and without post-bariatric hypoglycemia. This involves infusions of safe, nonradioactive forms of glucose and glucagon, eating a test meal, and liver scans before and after eating.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Post-Bariatric Hypoglycemia (PBH)Experimental Treatment5 Interventions
Group II: RYGB non-hypoglycemiaActive Control5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Joslin Diabetes Center

Lead Sponsor

Trials
98
Recruited
26,500+

University of Alabama at Birmingham

Collaborator

Trials
1,677
Recruited
2,458,000+

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

Collaborator

Trials
2,513
Recruited
4,366,000+