Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia

Post-Bariatric Hypoglycemia Clinical Trial

Official title:

Role of Nutrient Transit and Incretin Hormones in Hyperinsulinemic Hypoglycemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04615546
• Other study ID #: 52254
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2020
• Est. completion date: June 2024

Study information

• Verified date: August 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Hyperinsulinism
• Hypoglycemia
• Nesidioblastosis
• Post-Bariatric Hypoglycemia

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Steady state plasma glucose (SSPG) as a measure of insulin sensitivity	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.	Baseline 4-hour SSPG
Primary	Rate of gastric emptying	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.	Baseline 4-hour scintigraphy procedure
Primary	Concentration of Glucagon-Like peptide 1 secretion augmentation of insulin secretion rate	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.	Baseline 4-hour graded-glucose infusion
Primary	Rate of clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL)	This endpoint applies to Remote Phase participants	40 days
Primary	Percent time in clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL)	This endpoint applies to Remote Phase participants	40 days
Primary	Rate of arrhythmia during hypoglycemia	This endpoint applies to Remote Phase participants	10 days