Post-Bariatric HypoglycemiaNCT07878494
Dietary, Medication, and Endoscopic Interventions for Post-Bariatric Hypoglycemia
A study testing Dietary Intervention, GLP-1 receptor agonist or Dual GIP/GLP-1 receptor agonist and Transoral Outlet Reduction (TORe) in people with Post-Bariatric Hypoglycemia, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post-Bariatric Hypoglycemia
- What is being tested?
- Dietary Intervention, GLP-1 receptor agonist or Dual GIP/GLP-1 receptor agonist and Transoral Outlet Reduction (TORe)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to Nov 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand the study, provide written informed consent, and comply with study procedures.
- History of an upper gastrointestinal surgical procedure associated with postprandial hypoglycemia performed at least one year before enrollment, including: Roux-en-Y gastric bypass (RYGB), vertical sleeve gastrectomy (VSG), Nissen fundoplication, or other upper gastrointestinal surgical procedures associated with postprandial hypoglycemia, as approved by the Principal Investigator.
- Stable body weight (less than 2 kg change during the 4 weeks before screening).
- History of postprandial hypoglycemia consistent with Whipple's triad:symptoms of hypoglycemia, documented blood glucose <54 mg/dL by plasma or fingerstick glucose, resolution of symptoms after carbohydrate administration.
- Able to tolerate oral nutrition.
- Additional arm-specific eligibility criteria apply (e.g., only participants with RYGB who are independently scheduled for clinically indicated TORe are eligible for the TORe arm).
Who cannot join
- Diabetes mellitus (fasting plasma glucose ≥126 mg/dL).
- Clinically significant liver, kidney, cardiovascular, or other major systemic disease that would increase study risk.
- Pregnancy or breastfeeding.
- Active vomiting, diarrhea, or inability to tolerate oral nutrition.
- Active peptic ulcer disease.
- Prior surgery, procedure, or medical condition that would substantially interfere with gastric emptying measurements or interpretation of study results.
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- Active psychiatric illness or eating disorder that would interfere with study participation.
- Alcohol or substance abuse that would interfere with safe participation.
- Participation in another interventional clinical trial that would interfere with this study.
- Additional medication-specific exclusion criteria apply to participants enrolled in the Medication Module (e.g., contraindications to the study medication).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stanford University
Palo Alto, California, 94304
Nina Shenoy, BS, 408-896-0134, nshenoy8@stanford.edu
About this study
Official title: Evaluation of Dietary, Pharmacologic, and Endoscopic Interventions for Post-Bariatric Hypoglycemia
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.
- Conditions
- Post-Bariatric Hypoglycemia
- Being tested
- Dietary Intervention, GLP-1 receptor agonist or Dual GIP/GLP-1 receptor agonist, Transoral Outlet Reduction (TORe)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionBehavioural
Standardized dietary interventions evaluating the effects of meal composition (carbohydrate alone, carbohydrate plus fat, and carbohydrate plus protein) on postprandial hypoglycemia.
GLP-1 receptor agonist or Dual GIP/GLP-1 receptor agonistDrug
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.
Transoral Outlet Reduction (TORe)Other
Endoscopic transoral outlet reduction (TORe) performed as part of routine clinical care. Research participants undergo study assessments before and after the clinically indicated procedure.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Intervention | Experimental | 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. Receives: Behavioral: Dietary Intervention |
| Medication Intervention | Experimental | 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. Receives: Drug: GLP-1 receptor agonist or Dual GIP/GLP-1 receptor agonist |
| TORe Evaluation | Experimental | 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. Receives: Other: Transoral Outlet Reduction (TORe) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Hypoglycemia Symptom Severity
Participant-reported symptoms associated with postprandial hypoglycemia, measured using the protocol-specified symptom questionnaire or diary.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completionNov 2030 (estimated)
- Study completionNov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Bariatric HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study consists of three independent, parallel intervention modules evaluating dietary, pharmacologic, and endoscopic approaches for post-bariatric hypoglycemia. Participants are not randomized and enroll only in the module(s) for which they are eligible. Each module is analyzed independently; interventions are not compared with one another.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Tracey McLaughlin, Stanford University
- Investigators
- Tracey MacLaughlin, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878494
- Sponsor's protocol ID
- 87775
- Status last verified
- Oct 2026
- First submitted
- 11 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No