Mapping the hormone behind Post-Surgery blood sugar crashes

NCT ID NCT07818707

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers at Joslin Diabetes Center are studying how the body processes glucose and glucagon after a meal in people who have had gastric bypass surgery. Some of these people develop low blood sugar after eating, a condition called post-bariatric surgery hypoglycemia. The study compares people with and without this condition. Participants receive infusions of safe, nonradioactive tracers and a special meal, and researchers use MRI to measure liver glycogen before and after eating. The goal is to understand the biology well enough to help design a glucagon pump system.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
glucagon and stable isotope tracers of glucose and glucagon
What this could lead to
If researchers map how glucagon and glucose behave after meals, this could inform the design of an automated glucagon pump system for people who experience low blood sugar after bariatric surgery.
What could go wrong
This is a small physiological study of 40 people at a single center. It measures metabolism rather than testing a treatment, so any pump system remains theoretical and years away.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * Documented hypoglycemia occurring only in the fasting state (\>12 hours fast); * Current diabetes, defined as hemoglobin A1c \>6.5% or use of diabetes medications, except for acarbose or miglitol; * Chronic kidney disease stage 4 or 5 (including end-stage renal disease); * Hepatic disease, including serum ALT or AST greater than 2 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin \< 3.0 g/dL; or serum bilirubin \> 2.0; * Congestive heart failure, NYHA class II, III or IV; * History of myocardial infarction, unstable angina or revascularization within the past 6 months. * Two or more risk factors for coronary artery disease including diabetes, uncontrolled hypertension, uncontrolled hyperlipidemia, and active tobacco use. * History of recurrent syncope (unrelated to hypoglycemia) or active diagnosis of a cardiac arrhythmia; * Current administration of β-blocker therapy; * History of a cerebrovascular accident; * Seizure disorder (other than with suspect or documented hypoglycemia); * Active treatment with long-acting (LAR) octreotide or pasireotide; * Active malignancy, except basal cell or squamous cell skin cancers; * Personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease); * Known insulinoma; * Major surgical operation within 30 days prior to screening; * Clinically significant anemia as defined as a hematocrit \< 33%; * Bleeding disorder, treatment with warfarin, or platelet count \<50,000; * Blood donation (1 pint of whole blood) within the past 2 months; * Active alcohol abuse or substance abuse; * Current administration of oral or parenteral corticosteroids; * Pregnancy and/ or lactation: For persons of childbearing potential: there is a requirement for a negative urine pregnancy test before any procedures. * Not enrolled in another study that uses an investigational drug for this condition.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Joslin Diabetes Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • University of Alabama

    RECRUITING

    Birmingham, Alabama, 35294, United States

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