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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
Post-bariatric surgery more than 6 months prior to signing the informed consent (not required for non-surgical controls)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 40 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 18 and 70 years old.
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I had weight loss surgery over 6 months ago.
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I have a history of low blood sugar due to high insulin levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 40 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreTrial 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: 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 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: 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 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.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,379 Previous Clinical Trials
17,333,333 Total Patients Enrolled
American Diabetes AssociationOTHER
137 Previous Clinical Trials
99,442 Total Patients Enrolled
Colleen Craig, MDStudy DirectorStanford University
1 Previous Clinical Trials
18 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a serious infection or illness in the last 2 weeks.I have or had an insulin-producing tumor.I am between 18 and 70 years old.I am not taking drugs that affect blood sugar levels recently.My kidney and liver functions are within normal limits.I am not pregnant or breastfeeding.I am a woman who can have children and am not using birth control.I had weight loss surgery over 6 months ago.I have a history of low blood sugar due to high insulin levels.
Research Study Groups:
This trial has the following groups:- Group 1: Remote Phase: Post-Bariatric Hypoglycemia Patients
- Group 2: In-Clinic Phase: Nonsurgical Controls
- Group 3: In-Clinic Phase: Post-Bariatric Hypoglycemia Patients
- Group 4: In-Clinic Phase: Post-Bariatric Hypoglycemia Patients with indwelling gastrostomy tube
- Group 5: In-Clinic Phase: Surgical Controls
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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