NCT04615546 Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia
| NCT ID | NCT04615546 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Post-Bariatric Hypoglycemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2020-05-06 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2020-05-06 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Tracey McLaughlin, MD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT04615546 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Post-Bariatric Hypoglycemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04615546 currently recruiting?
Yes, NCT04615546 is actively recruiting participants. Visit ClinicalTrials.gov or contact Stanford University to inquire about joining.
Where is the NCT04615546 trial being conducted?
This trial is being conducted at Stanford, United States.
Who is sponsoring the NCT04615546 clinical trial?
NCT04615546 is sponsored by Stanford University. The principal investigator is Tracey McLaughlin, MD at Stanford University. The trial plans to enroll 60 participants.