Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia

Not Applicable

Recruiting

• Conditions: Post-Bariatric Hypoglycemia
• Interventions: Behavioral: Use of Continuous Glucose Monitor (CGM); Other: Use of "Cardea Solo" monitoring

• Registration Number: NCT04615546
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-06
• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-10-29
• Study First Posted: 2020-11-04
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote Phase: Post-Bariatric Hypoglycemia Patients	Use of Continuous Glucose Monitor (CGM)	Participants will wear continuous glucose monitor (CGM) in a blinded manner (cannot see data output) for 20 days followed by in an unblinded manner (can see data output) for 20 days.
Remote Phase: Post-Bariatric Hypoglycemia Patients	Use of "Cardea Solo" monitoring	Participants will wear continuous glucose monitor (CGM) in a blinded manner (cannot see data output) for 20 days followed by in an unblinded manner (can see data output) for 20 days.

Primary Outcome Measures

Name	Time	Method
Steady state plasma glucose (SSPG) as a measure of insulin sensitivity	Baseline 4-hour SSPG	This endpoint applies to the In-Clinic Phase cohorts: Post-Bariatric Hypoglycemia, Surgical Controls, Non-Surgical Controls. This is a one day in-person appointment lasting approximately 6 hours.
Rate of gastric emptying	Baseline 4-hour scintigraphy procedure	This endpoint applies to the In-Clinic Phase cohorts: Post-Bariatric Hypoglycemia, Surgical Controls, Non-Surgical Controls. This is an in-person appointment lasting approximately 5 hours.
Concentration of Glucagon-Like peptide 1 secretion augmentation of insulin secretion rate	Baseline 4-hour graded-glucose infusion	This endpoint applies to the In-Clinic Phase cohorts: Post-Bariatric Hypoglycemia, Surgical Controls, Non-Surgical Controls. The blood collected from the SSPG will be stored and analyzed for the concentration of GLP-1 at multiple timepoints.
Rate of clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL)	40 days	This endpoint applies to Remote Phase participants
Rate of arrhythmia during hypoglycemia	10 days	This endpoint applies to Remote Phase participants
Percent time in clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL)	40 days	This endpoint applies to Remote Phase participants

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States