Actively Recruiting
Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia
Led by Stanford University · Updated on 2024-12-04
60
Participants Needed
1
Research Sites
316 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
A
American Diabetes Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Stanford University School of Medicine
Stanford, California, United States, 94305-5103
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
5
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