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NOT YET RECRUITING
NCT07878494
NA

Dietary, Medication, and Endoscopic Interventions for Post-Bariatric Hypoglycemia

Sponsor: Stanford University

View on ClinicalTrials.gov

Summary

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.

Official title: Evaluation of Dietary, Pharmacologic, and Endoscopic Interventions for Post-Bariatric Hypoglycemia

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-11-01

Completion Date

2031-11

Last Updated

2026-10-16

Healthy Volunteers

No

Interventions

BEHAVIORAL

Dietary Intervention

Standardized dietary interventions evaluating the effects of meal composition (carbohydrate alone, carbohydrate plus fat, and carbohydrate plus protein) on postprandial hypoglycemia.

DRUG

GLP-1 receptor agonist or Dual GIP/GLP-1 receptor agonist

Treatment with a GLP-1 receptor agonist (semaglutide) or dual GIP/GLP-1 receptor agonist (tirzepatide) administered for approximately 12 weeks to evaluate its effects on postprandial hypoglycemia.

OTHER

Transoral Outlet Reduction (TORe)

Endoscopic transoral outlet reduction (TORe) performed as part of routine clinical care. Research participants undergo study assessments before and after the clinically indicated procedure.

Locations (1)

Stanford University

Palo Alto, California, United States