Clinical trial NCT04615546: Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia
Official title: Role of Nutrient Transit and Incretin Hormones in Hyperinsulinemic Hypoglycemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-Bariatric Hypoglycemia
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2020-11-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Steady state plasma glucose (SSPG) as a measure of insulin sensitivity
timeFrame: Baseline 4-hour SSPG
measure: Rate of gastric emptying
timeFrame: Baseline 4-hour scintigraphy procedure
measure: Concentration of Glucagon-Like peptide 1 secretion augmentation of insulin secretion rate
timeFrame: Baseline 4-hour graded-glucose infusion
measure: Rate of clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL)
timeFrame: 40 days
measure: Percent time in clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL)
timeFrame: 40 days
measure: Rate of arrhythmia during hypoglycemia
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Tracey McLaughlin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Colleen Craig, MD
role: STUDY_DIRECTOR
References: