RECRUITING

Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Role of Nutrient Transit and Incretin Hormones in Hyperinsulinemic Hypoglycemia

Quick Facts

Study Start:2020-05-06
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04615546

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female patients 18-70 years of age
  2. * Post-bariatric surgery more than 6 months prior to signing the informed consent (not required for non-surgical controls)
  3. * Documented history of hyperinsulinemic hypoglycemia (not required for post-bariatric and non-surgical controls)
  1. * Patients currently using sulfonylureas or other medications that may interfere with glucose metabolism within 5 half-lives of drug.
  2. * Participation in any clinical investigation within 4 weeks prior to dosing
  3. * History of or current insulinoma
  4. * Active infection or significant acute illness within 2 weeks prior to dosing
  5. * Female patients who are pregnant or lactating
  6. * Women of childbearing potential and not utilizing effective contraceptive methods
  7. * 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
  8. * Allergy to test meal or medications used in the study

Contacts and Locations

Principal Investigator

Tracey McLaughlin, MD
PRINCIPAL_INVESTIGATOR
Stanford University
Colleen Craig, MD
STUDY_DIRECTOR
Stanford University

Study Locations (Sites)

Stanford University School of Medicine
Stanford, California, 94305-5103
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Tracey McLaughlin, MD, PRINCIPAL_INVESTIGATOR, Stanford University
  • Colleen Craig, MD, STUDY_DIRECTOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-05-06
Study Completion Date2026-06

Study Record Updates

Study Start Date2020-05-06
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Post-Bariatric Hypoglycemia