Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Use of Continuous Glucose Monitor (CGM), Use of "Cardea Solo" monitoring.
- Who it may be relevant to
- Registry conditions: Post-Bariatric Hypoglycemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Role of Nutrient Transit and Incretin Hormones in Hyperinsulinemic Hypoglycemia
Overview
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.
Interventions
- Behavioral Use of Continuous Glucose Monitor (CGM)
Participants will wear CGM - Other Use of "Cardea Solo" monitoring
Participants will wear a "Cardea Solo" patch during blinded CGM use
Primary outcome measures
- Steady state plasma glucose (SSPG) as a measure of insulin sensitivity [Time frame: Baseline 4-hour SSPG]
- Rate of gastric emptying [Time frame: Baseline 4-hour scintigraphy procedure]
- Concentration of Glucagon-Like peptide 1 secretion augmentation of insulin secretion rate [Time frame: Baseline 4-hour graded-glucose infusion]
- Rate of clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL) [Time frame: 40 days]
- Percent time in clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL) [Time frame: 40 days]
- Rate of arrhythmia during hypoglycemia [Time frame: 10 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Stanford University School of Medicine — Stanford
Identifiers
NCT: NCT04615546 · 52254