Mapping the hormone behind Post-Surgery blood sugar crashes
NCT ID NCT07818707
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Joslin Diabetes Center
RECRUITINGBoston, Massachusetts, 02215, United States
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University of Alabama
RECRUITINGBirmingham, Alabama, 35294, United States
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