An interventional study of Dietary Intervention and GLP-1 receptor agonist or Dual GIP/GLP-1 receptor agonist in Post-Bariatric Hypoglycemia, sponsored by Stanford University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
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.
Stanford University is the lead sponsor of 2,161 studies on the registry; 428 are open to participants now.
Of its 268 completed or terminated interventional studies of FDA-regulated products, 207 (77%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Dietary Intervention
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.
Drug: GLP-1 receptor agonist or Dual GIP/GLP-1 receptor agonist
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.
Other: Transoral Outlet Reduction (TORe)
Standardized dietary interventions evaluating the effects of meal composition (carbohydrate alone, carbohydrate plus fat, and carbohydrate plus protein) on postprandial hypoglycemia.
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.
Endoscopic transoral outlet reduction (TORe) performed as part of routine clinical care. Research participants undergo study assessments before and after the clinically indicated procedure.
Postprandial Glucose Nadir Following Standardized Test Meals
The lowest glucose concentration measured by continuous glucose monitoring following standardized meals containing carbohydrate alone, carbohydrate plus fat, and carbohydrate plus protein. Glucose nadirs will be compared across the three meal conditions within participants.
Time frame: During the Diet Arm, approximately 2 to 4 weeks
Plasma Glucose Nadir During the Solid Mixed Meal Tolerance Test
The lowest plasma glucose concentration measured during the standardized solid mixed meal tolerance test. Values obtained during treatment will be compared with baseline values within participants.
Time frame: 12 weeks
Plasma Glucose Nadir During the Liquid Mixed Meal Tolerance Test
The lowest plasma glucose concentration measured during the standardized liquid mixed meal tolerance test. Post-procedure values will be compared with baseline values within participants.
Time frame: 12 weeks
Gastric Emptying Measured by One-Hour Residual Activity
Percentage of radiolabeled meal remaining in the stomach or gastric pouch one hour after meal ingestion during gastric emptying scintigraphy. Higher residual activity indicates slower gastric emptying.
Time frame: 12 weeks
Postprandial Glucose Peak-to-Nadir Change Measured by CGM
Difference between the highest and lowest glucose concentrations following standardized meals, measured by continuous glucose monitoring.
Time frame: 12 weeks
Postprandial Insulin Response During the MMTT
Plasma insulin concentrations measured during the mixed meal tolerance test, summarized using peak insulin concentration and area under the concentration-time curve.
Time frame: 12 weeks
Postprandial GLP-1 and GIP Responses During the MMTT
Plasma GLP-1 and GIP concentrations measured during the mixed meal tolerance test, summarized using peak concentrations and area under the concentration-time curve.
Time frame: 12 weeks
Hypoglycemia Symptom Severity
Participant-reported symptoms associated with postprandial hypoglycemia, measured using the protocol-specified symptom questionnaire or diary.
Time frame: 12 weeks
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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