Dietary, Medication, and Endoscopic Interventions for Reactive Hypoglycemia
What You Need to Know Before You Apply
What is the purpose of this trial?
Post-bariatric hypoglycemia (PBH) is a complication of upper gastrointestinal surgery that causes recurrent episodes of low blood sugar after eating and can substantially impair quality of life. Currently, there are no approved therapies specifically indicated for PBH.
The purpose of this study is to better understand the physiological mechanisms underlying PBH and to evaluate three therapeutic approaches that may reduce hypoglycemia: dietary modification, treatment with a GLP-1 receptor agonist or dual GIP/GLP-1 receptor agonist, and transoral outlet reduction (TORe). Participants will undergo detailed metabolic testing, including continuous glucose monitoring, mixed meal tolerance testing, and gastric emptying scintigraphy, to determine how these interventions affect gastric emptying, glucose regulation, insulin secretion, gut hormone responses, and hypoglycemia.
Who Is on the Research Team?
Tracey MacLaughlin, MD
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
This trial is for people who have low blood sugar episodes after bariatric (weight loss) surgery. Participants should be adults with a history of post-bariatric hypoglycemia and able to undergo metabolic testing.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Dietary Intervention
- GLP-1 receptor agonist or Dual GIP/GLP-1 receptor agonist
- Transoral Outlet Reduction (TORe)
Trial Overview
The study compares three ways to manage low blood sugar after weight loss surgery: changes in diet, certain diabetes medications (GLP-1 or GIP/GLP-1 receptor agonists), and an endoscopic procedure called TORe. Effects on blood sugar control are closely monitored.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Participants who independently elect to undergo transoral outlet reduction (TORe) as part of their routine clinical care undergo research assessments before and at least 12 weeks after the procedure. Study assessments include continuous glucose monitoring (CGM), mixed meal tolerance testing (MMTT), gastric emptying scintigraphy, blood sampling, and questionnaires.
Participants receive treatment with a GLP-1 receptor agonist (semaglutide) or dual GIP/GLP-1 receptor agonist (tirzepatide) for approximately 12 weeks. Study assessments include continuous glucose monitoring (CGM), mixed meal tolerance testing (MMTT), gastric emptying scintigraphy, blood sampling, and questionnaires at baseline, approximately 6 weeks, and approximately 12 weeks.
Participants undergo standardized dietary interventions designed to evaluate the effects of meal composition on postprandial hypoglycemia. Study assessments include continuous glucose monitoring (CGM), mixed meal tolerance testing (MMTT), gastric emptying scintigraphy, blood sampling, and questionnaires.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.