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Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia

NCT ID: NCT04615546

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-06

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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Post-Bariatric Hypoglycemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Use of Continuous Glucose Monitor (CGM)

Intervention Type BEHAVIORAL

Participants will wear CGM

Use of "Cardea Solo" monitoring

Intervention Type OTHER

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Use of Continuous Glucose Monitor (CGM)

Participants will wear CGM

Intervention Type BEHAVIORAL

Use of "Cardea Solo" monitoring

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Diabetes Association

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Tracey McLaughlin

Professor of Medicine, Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tracey McLaughlin, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Colleen Craig, MD

Role: STUDY_DIRECTOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Colleen Craig, MD

Role: primary

[email protected]
650-724-2474

Other Identifiers

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52254

Identifier Type: -

Identifier Source: org_study_id