Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

About this trial

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

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

60 Participants
are divided into 5 treatment groups

Sponsors and collaborators

Stanford University

Lead sponsor

American Diabetes Association

Collaborator