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Gut microbiome linked to hypoglycemia in new study

NCT ID NCT03385707

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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.
Paused
Paused for now. It may or may not start again.
Ongoing This study
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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looks at 28 people who experience low blood sugar (hypoglycemia) after eating, often due to past stomach surgery. Researchers want to see if the types of bacteria in the gut are linked to how often and how severely blood sugar drops. Participants wear a continuous glucose monitor and provide stool samples to analyze their microbiome.

What this could mean

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

What this could lead to
If successful, this could point toward new ways to manage or predict hypoglycemia by understanding gut bacteria.
What could go wrong
This is a small, observational study with only 28 participants, so results may not apply widely. It looks for correlations, not treatments.

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.

Participants

About 28 people

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

Started

Feb 2019

Expected to finish

Nov 2026

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.

Who is studied

Patients who experience hypoglycemia after bariatric or other upper gastrointestinal surgery or those with reactive hypoglycemia in the absence of surgery.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 1. Males or females diagnosed with ongoing post-bariatric, post-gastric surgery or other forms of postprandial hypoglycemia with prior episodes of neuroglycopenia 2. Age 18-65 years of age, inclusive, at screening. 3. Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits. Exclusion Criteria 1. Documented hypoglycemia occurring in the fasting state (\> 12 hours fast); 2. Chronic kidney disease stage 4 or 5 (including end-stage renal disease); 3. Hepatic disease, including serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than or equal to 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin \< 3.0 g/dL; or serum bilirubin \> 2.0; 4. Congestive heart failure, New York Heart Association (NYHA) class II, III or IV; 5. History of myocardial infarction, unstable angina or revascularization within the past 6 months or 2 or more risk factors for coronary artery disease including diabetes, uncontrolled hypertension, uncontrolled hyperlipidemia, and active tobacco use. 6. History of syncope (unrelated to hypoglycemia) or diagnosed cardiac arrhythmia 7. Concurrent administration of β-blocker therapy; 8. History of a cerebrovascular accident; 9. Seizure disorder (other than with suspect or documented hypoglycemia); 10. Active treatment with any diabetes medications except for acarbose; 11. Active treatment with octreotide or diazoxide; 12. Active malignancy, except basal cell or squamous cell skin cancers; 13. Personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease); 14. Known insulinoma; 15. Major surgical operation within 30 days prior to screening; 16. Hematocrit \< 33%; 17. Bleeding disorder, treatment with warfarin, or platelet count \<50,000; 18. Blood donation (1 pint of whole blood) within the past 2 months; 19. Active alcohol abuse or substance abuse; 20. Current administration of oral or parenteral corticosteroids; 21. Pregnancy and/ or lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 1 month after participating in the study. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an intrauterine device (IUD), the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence. 22. Use of an investigational drug within 30 days prior to screening.

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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.

Contacts and locations

Locations

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.