Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia

NCT04615546 | Recruiting

• 1 other identifier: 52254
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Bariatric Hypoglycemia

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• Rate of clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL)

  This endpoint applies to Remote Phase participants

  40 days

• Percent time in clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL)

  This endpoint applies to Remote Phase participants

  40 days

• Rate of arrhythmia during hypoglycemia

  This endpoint applies to Remote Phase participants

  10 days

Study Arms (5)

Remote Phase: Post-Bariatric Hypoglycemia Patients

EXPERIMENTAL

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.

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

In-Clinic Phase: Post-Bariatric Hypoglycemia Patients

NO INTERVENTION

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

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

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

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

Interventions

Use of Continuous Glucose Monitor (CGM) BEHAVIORAL

Participants will wear CGM

Remote Phase: Post-Bariatric Hypoglycemia Patients

Use of "Cardea Solo" monitoring OTHER

Participants will wear a "Cardea Solo" patch during blinded CGM use

Remote Phase: Post-Bariatric Hypoglycemia Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• American Diabetes Association: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305-5103, United States

RECRUITING

Study Officials

• Tracey McLaughlin, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Colleen Craig, MD

  Stanford University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Endocrinology

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 4, 2020
• Study Start: May 6, 2020
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)