Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia

Stanford University

Status: Enrolling

Conditions: Post-Bariatric Hypoglycemia

Treatments: Other: Use of "Cardea Solo" monitoring; Behavioral: Use of Continuous Glucose Monitor (CGM)

Study type: Interventional

Funder types: Other

Identifiers

NCT04615546

52254

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 5 patient groups

Remote Phase: Post-Bariatric Hypoglycemia Patients

Experimental group

Description:

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.

Treatment:

Behavioral: Use of Continuous Glucose Monitor (CGM)

Other: Use of "Cardea Solo" monitoring

In-Clinic Phase: Post-Bariatric Hypoglycemia Patients

No Intervention group

Description:

Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions. This group will also wear CGM during a portion of the metabolic tests. This may include participants from the Remote Phase or newly enrolled participants.

In-Clinic Phase: Surgical Controls

No Intervention group

Description:

Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions.

In-Clinic Phase: Nonsurgical Controls

No Intervention group

Description:

Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions.

In-Clinic Phase: Post-Bariatric Hypoglycemia Patients with indwelling gastrostomy tube

No Intervention group

Description:

Participants will undergo standardized mixed meal tolerance tests via oral, gastrostomy tube, and concomitant oral + gastrostomy tube routes of delivery with metabolic parameters assessed.