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Monitoring Techniques for Post-Bariatric Hypoglycemia

N/A
Recruiting
Led By Tracey McLaughlin, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female patients 18-70 years of age
Be older than 18 years old
Must not have
Active infection or significant acute illness within 2 weeks prior to dosing
History of or current insulinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 40 days
Awards & highlights
No Placebo-Only Group

Summary

This trial investigates why some patients develop severe hypoglycemia after gastric bypass surgery and aims to develop better prevention and treatment approaches.

Who is the study for?
This trial is for adults aged 18-70 who've had bariatric surgery over 6 months ago and have documented low blood sugar due to high insulin. It's not for those with a tumor causing high insulin, recent acute illness, pregnant or breastfeeding women, or anyone on certain diabetes drugs.
What is being tested?
The study tests how 'Cardea Solo' monitoring and Continuous Glucose Monitors (CGM) can help understand why some patients develop severe hypoglycemia after gastric bypass surgery. The goal is to improve prediction and treatment of this condition.
What are the potential side effects?
While the trial involves monitoring devices rather than medications, potential side effects may include skin irritation from device adhesives or discomfort during glucose level testing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had a serious infection or illness in the last 2 weeks.
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I have or had an insulin-producing tumor.
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My kidney and liver functions are within normal limits.
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I am not pregnant or breastfeeding.
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I am a woman who can have children and am not using birth control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 40 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Concentration of Glucagon-Like peptide 1 secretion augmentation of insulin secretion rate
Percent time in clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL)
Rate of arrhythmia during hypoglycemia
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Remote Phase: Post-Bariatric Hypoglycemia PatientsExperimental Treatment2 Interventions
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 II: In-Clinic Phase: Post-Bariatric Hypoglycemia Patients with indwelling gastrostomy tubeActive Control1 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.
Group III: In-Clinic Phase: Post-Bariatric Hypoglycemia PatientsActive Control1 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.
Group IV: In-Clinic Phase: Nonsurgical ControlsActive Control1 Intervention
Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions.
Group V: In-Clinic Phase: Surgical ControlsActive Control1 Intervention
Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,491 Previous Clinical Trials
17,519,152 Total Patients Enrolled
American Diabetes AssociationOTHER
146 Previous Clinical Trials
101,619 Total Patients Enrolled
Colleen Craig, MDStudy DirectorStanford University
1 Previous Clinical Trials
18 Total Patients Enrolled
Tracey McLaughlin, MDPrincipal Investigator - Stanford University
Stanford Hospital, Stanford Hospital and Clinic
University Of California (Medical School)
Stanford University Hospital (Residency)
10 Previous Clinical Trials
724 Total Patients Enrolled

Media Library

Remote Phase: Post-Bariatric Hypoglycemia Patients Clinical Trial Eligibility Overview. Trial Name: NCT04615546 — N/A
Reactive Hypoglycemia Research Study Groups: In-Clinic Phase: Post-Bariatric Hypoglycemia Patients with indwelling gastrostomy tube, In-Clinic Phase: Post-Bariatric Hypoglycemia Patients, In-Clinic Phase: Nonsurgical Controls, Remote Phase: Post-Bariatric Hypoglycemia Patients, In-Clinic Phase: Surgical Controls
Reactive Hypoglycemia Clinical Trial 2023: Remote Phase: Post-Bariatric Hypoglycemia Patients Highlights & Side Effects. Trial Name: NCT04615546 — N/A
Remote Phase: Post-Bariatric Hypoglycemia Patients 2023 Treatment Timeline for Medical Study. Trial Name: NCT04615546 — N/A
~10 spots leftby Dec 2025
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