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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
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

No Intervention

No Intervention

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 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

First Posted
October 29, 2020
Last Updated
August 10, 2023
Sponsor
Stanford University
Collaborators
American Diabetes Association
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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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
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.
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
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.
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
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
Email
cmcraig@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia

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