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

What Was Tested

This registered phase 4 trial tested Glucagon.

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.

It had two arms (groups): RYGB non-hypoglycemia (active comparator) and Post-Bariatric Hypoglycemia (PBH) (experimental).

Individuals that underwent Roux-en-y gastric bypass (RYGB) at least 2 years prior to recruitment and do not have a diagnosis of PBH.

Individuals that underwent RYGB at least 2 years prior to recruitment and have a diagnosis of PBH.

The registry classes the interventions as drug.

More on the Plan

The purpose of this study is to assess post-prandial carbohydrate, hormone, and hepatic glycogen metabolism comparing individuals with post-bariatric surgery hypoglycemia (PBH+) to individuals post-bariatric surgery without hypoglycemia (PBH-).

During Visit 1, the participants will undergo a medical history, physical examination, vital signs, and ECG; inclusion/exclusion criteria will be assessed.

Participants will also be advised to complete food log entries and to follow a low glycemic index diet.

At Visit 2, a continuous glucose monitor (CGM sensor) in masked mode will be placed on the participant.

Who Took Part

40 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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 at least 2 years following Roux-en-Y gastric bypass (RYGB). For patients recruited to PBH group: diagnosed with ongoing PBH, with documented episodes of hypoglycemia, and history of fulfillment of Whipple's triad.

The full record lists 4 inclusion and 23 exclusion criteria; among the exclusions: documented hypoglycemia occurring only in the fasting state (\>12 hours fast);; congestive heart failure, nyha class ii, iii or iv;; history of myocardial infarction, unstable angina or revascularization within the past 6 months.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Glucagon study did not mask who received what.

It started in 2026-01-27 with completion listed for 2027-01.

It ran at 2 sites in United States (2).

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Between-group differences in iAUC for postprandial EGP (time frame: During Visit 2, within 10 days of the baseline visit).

It also tracked 8 secondary outcomes, for example Between-group differences in the integrated postprandial response (iAUC) of Ra glucagon, Between-group differences in EGP in the fasting state, Between-group differences in iAUC for glucose levels for 60 minutes after postprandial glucagon administration, Between-group differences in insulin sensitivity, as estimated by postprandial SI derived from oral glucose minimal model, Between-group differences in insulin secretion, as estimated by postprandial phi total and Between-group differences in disposition index derived from oral glucose minimal model.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Glucagon in 40 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glucagon compound page, all human trials.