ClinicalTrials.gov record NCT04615546

Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

Role of Nutrient Transit and Incretin Hormones in Hyperinsulinemic Hypoglycemia

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This interventional study seeks to understand physiological changes after gastric bypass that lead to symptomatic low blood sugar (post-bariatric hypoglycemia). It includes people with post-bariatric hypoglycemia and comparison groups (surgical and non-surgical controls). Participants may wear a continuous glucose monitor at home and attend 1–3 in-clinic metabolic testing visits.

What it is studying. The study tests whether the speed of nutrient transit through the gut and the release of incretin gut hormones (for example, Glucagon-Like peptide 1) are linked to excessive insulin release and episodes of low blood sugar after gastric bypass. It also measures insulin sensitivity, gastric emptying, the frequency and time spent in clinically important hypoglycemia, and heart rhythm during hypoglycemia.

What the researchers hope to learn. To define physiological differences after gastric bypass that are associated with symptomatic hypoglycemia by measuring insulin sensitivity (SSPG), gastric emptying rate, GLP-1–related augmentation of insulin secretion, rates and percent time in clinically important hypoglycemia (<54 mg/dL), and arrhythmia during hypoglycemia. The findings aim to inform prediction, prevention, and future research on treatments.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Severe hypoglycemia (low blood sugar)after gastric bypass surgery is an increasingly recognized condition, characterized by symptoms of hypoglycemia after eating and inappropriately elevated insulin concentrations that occur at the time of hypoglycemia. Severe hypoglycemia can be dangerous and debilitating and can also impact cognitive function. At the moment no medical therapies have been developed for this disorder. Determining why some but not other patients develop this condition would allow for improved prediction, prevention, and treatment approaches. The purpose of the study is to understand the physiological changes observed in those patients who undergo gastric bypass and develop symptomatic hypoglycemia.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Behavioral
  • Use of Continuous Glucose Monitor (CGM)
Other
  • Use of "Cardea Solo" monitoring

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Male or female patients 18-70 years of age
  • Post-bariatric surgery more than 6 months prior to signing the informed consent (not required for non-surgical controls)
  • Documented history of hyperinsulinemic hypoglycemia (not required for post-bariatric and non-surgical controls)

Exclusion criteria

  • Patients currently using sulfonylureas or other medications that may interfere with glucose metabolism within 5 half-lives of drug.
  • Participation in any clinical investigation within 4 weeks prior to dosing
  • History of or current insulinoma
  • Active infection or significant acute illness within 2 weeks prior to dosing
  • Female patients who are pregnant or lactating
  • Women of childbearing potential and not utilizing effective contraceptive methods
  • Inadequate end organ function as defined by: Serum creatinine >2.0 mg/dL, alanine transaminase (ALT) and aspartate aminotransferase (AST) > 2 x Upper Normal Limit
  • Allergy to test meal or medications used in the study

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participation may include wearing a continuous glucose monitor (CGM) — for the remote phase participants this is 20 days while blinded followed by 20 days unblinded — and wearing a Cardea Solo patch during the blinded period. Some participants will attend 1–3 in‑clinic visits over about two months for multi‑hour metabolic testing (for example a ~6‑hour steady‑state plasma glucose test and a ~5‑hour gastric emptying scintigraphy), blood draws for hormone measurements, and mixed‑meal tests; a subgroup with an indwelling gastrostomy tube may receive standardized meals via the tube (and by mouth) during testing. Clinic tests may include CGM monitoring during portions of the assessments.

How the study is structured. Interventional, non-randomized, parallel, open-label study. Remote phase (post-bariatric hypoglycemia group): participants wear a continuous glucose monitor (CGM) blinded for 20 days then unblinded for 20 days; a Cardea Solo patch is worn during the blinded period. In-clinic phase: participants (post-bariatric hypoglycemia, surgical controls, nonsurgical controls) attend 1–3 visits over about 2 months for metabolic testing, including a one-day steady-state plasma glucose visit (~6 hours), a gastric emptying scintigraphy (~5 hours), graded-glucose infusion with blood sampling, and mixed-meal tests. A subgroup with an indwelling gastrostomy tube may undergo mixed-meal tests given by oral, tube, and combined routes.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on congenital hyperinsulinism

Clinical trials5 trials listed for congenital hyperinsulinismEvery trial the registry lists for congenital hyperinsulinism, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in congenital hyperinsulinism researchLatest monthly update: September 2026. Includes: After-surgery medicines. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
May 6, 2020
Primary completion
December 2025 (estimated)
Study completion
June 2026 (estimated)
Target enrollment
60 participants (estimated)
Last updated on registry
Dec 4, 2024
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Stanford University
Principal investigator
Tracey McLaughlin, Professor of Medicine, Endocrinology
Stanford University
Collaborators
  • American Diabetes Association

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
5 half-lives
The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
Women of childbearing potential
Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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