Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia
Recruiting now · Not applicable
Conditions studied: Post-Bariatric Hypoglycemia
In brief
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.
Key facts
- Study ID
- NCT04615546
- Run by
- Stanford University
- People needed
- 60
- Starts
- 2020-05-06
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2024-12-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Stanford University School of Medicine — Stanford, California, United States (enrolling)
Full record on ClinicalTrials.gov
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