Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia

Conditions

• Post-Bariatric Hypoglycemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Use of Continuous Glucose Monitor (CGM) — BEHAVIORAL
  Participants will wear CGM
• Use of "Cardea Solo" monitoring — OTHER
  Participants will wear a "Cardea Solo" patch during blinded CGM use

Study Details

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.

Key Dates

Start date

May 6, 2020

Status verified

Dec 2024

Primary completion

Dec 31, 2025

Completion

Jun 30, 2026

Study Design

Enrollment

60 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Remote Phase: Post-Bariatric Hypoglycemia Patients
  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.
• No Intervention: In-Clinic Phase: Post-Bariatric Hypoglycemia Patients
  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.
• No Intervention: In-Clinic Phase: Surgical Controls
  Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions.
• No Intervention: In-Clinic Phase: Nonsurgical Controls
  Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions.
• No Intervention: In-Clinic Phase: Post-Bariatric Hypoglycemia Patients with indwelling gastrostomy tube
  Participants will undergo standardized mixed meal tolerance tests via oral, gastrostomy tube, and concomitant oral + gastrostomy tube routes of delivery with metabolic parameters assessed.

Primary Outcome Measure

Steady state plasma glucose (SSPG) as a measure of insulin sensitivity [ Time Frame: Baseline 4-hour SSPG ]

Locations (1)

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