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Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia

NCT04615546 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-12-04

No results posted yet for this study

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.

Conditions

  • Post-Bariatric Hypoglycemia

Interventions

BEHAVIORAL

Use of Continuous Glucose Monitor (CGM)

Participants will wear CGM

OTHER

Use of "Cardea Solo" monitoring

Participants will wear a "Cardea Solo" patch during blinded CGM use

Sponsors & Collaborators

Principal Investigators

  • Tracey McLaughlin, MD · Stanford University

  • Colleen Craig, MD · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-06
Primary Completion
2025-12-31
Completion
2026-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04615546 on ClinicalTrials.gov