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RECRUITING
NCT07818707
PHASE4

Post-Prandial Carbohydrate Metabolism in Individuals With and Without Post-Bariatric Surgery Hypoglycemia (PBH)

Sponsor: Joslin Diabetes Center

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-01-27

Completion Date

2027-01

Last Updated

2026-09-14

Healthy Volunteers

Yes

Interventions

DRUG

Glucagon for Injection (Fresenius Kabi USA)

The investigators are assessing glucagon metabolism in individuals with and without PBH in fasting and post-prandial states.

DRUG

[6,6-2H2] glucose

The investigators are using a stable isotope glucose tracer to assess glucose metabolism in individuals with and without PBH in fasting and post-prandial states.

DRUG

[13C9, 15N1]-glucagon

The investigators are assessing the metabolism of glucagon in individuals with and without PBH in fasting and post-prandial states.

DRUG

[1-13C] glucose

The investigators are assessing the metabolism of glucose in individuals with and without PBH in fasting and post-prandial states.

DRUG

[2-13C] glucose

The investigators assessing the metabolism of glucose in individuals with and without PBH in fasting and post-prandial states.

Locations (2)

University of Alabama

Birmingham, Alabama, United States

Joslin Diabetes Center

Boston, Massachusetts, United States