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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 40 days

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.

0 / 6Eligibility criteria met