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Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia

Primary Purpose

Post-Bariatric Hypoglycemia

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Use of Continuous Glucose Monitor (CGM)

Use of "Cardea Solo" monitoring

About this trial

This is an interventional prevention trial for Post-Bariatric Hypoglycemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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, ALT and AST > 2 x UNL
Allergy to test meal or medications used in the study

Sites / Locations

Stanford University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

No Intervention

Arm Label

Remote Phase: Post-Bariatric Hypoglycemia Patients

In-Clinic Phase: Post-Bariatric Hypoglycemia Patients

In-Clinic Phase: Surgical Controls

In-Clinic Phase: Nonsurgical Controls

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

Arm 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.

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.

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

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

Outcomes

Primary Outcome Measures

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.

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.

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.

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

This endpoint applies to Remote Phase participants

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

This endpoint applies to Remote Phase participants

Rate of arrhythmia during hypoglycemia

This endpoint applies to Remote Phase participants

Secondary Outcome Measures

Full Information

NCT ID

NCT04615546

First Posted

October 29, 2020

Last Updated

August 10, 2023

Sponsor

Stanford University

Collaborators

American Diabetes Association

1. Study Identification

Unique Protocol Identification Number

NCT04615546

Brief Title

Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia

Official Title

Role of Nutrient Transit and Incretin Hormones in Hyperinsulinemic Hypoglycemia

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 6, 2020 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

American Diabetes Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-Bariatric Hypoglycemia

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Remote Phase: Post-Bariatric Hypoglycemia Patients

Arm Type

Experimental

Arm 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.

Arm Title

In-Clinic Phase: Post-Bariatric Hypoglycemia Patients

Arm Type

No Intervention

Arm Description

Arm Title

In-Clinic Phase: Surgical Controls

Arm Type

No Intervention

Arm Description

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

Arm Title

In-Clinic Phase: Nonsurgical Controls

Arm Type

No Intervention

Arm Description

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

Arm Title

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

Arm Type

No Intervention

Arm 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.

Intervention Type

Behavioral

Intervention Name(s)

Use of Continuous Glucose Monitor (CGM)

Intervention Description

Participants will wear CGM

Intervention Type

Other

Intervention Name(s)

Use of "Cardea Solo" monitoring

Intervention Description

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

Primary Outcome Measure Information:

Title

Steady state plasma glucose (SSPG) as a measure of insulin sensitivity

Description

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.

Time Frame

Baseline 4-hour SSPG

Title

Rate of gastric emptying

Description

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.

Time Frame

Baseline 4-hour scintigraphy procedure

Title

Concentration of Glucagon-Like peptide 1 secretion augmentation of insulin secretion rate

Description

Time Frame

Baseline 4-hour graded-glucose infusion

Title

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

Description

This endpoint applies to Remote Phase participants

Time Frame

40 days

Title

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

Description

This endpoint applies to Remote Phase participants

Time Frame

40 days

Title

Rate of arrhythmia during hypoglycemia

Description

This endpoint applies to Remote Phase participants

Time Frame

10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tracey McLaughlin, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Colleen Craig, MD

Organizational Affiliation

Stanford University

Official's Role

Study Director

Facility Information:

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305-5103

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Colleen Craig, MD

Phone

650-724-2474

cmcraig@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia

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