Not yet recruitingPhase NA

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

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

Lead sponsor

Stanford University

Assets

Semaglutide / Tirzepatide

Listed sites

Recruiting sites

Estimated enrollment

Study population

Prediabetes / glucose intolerance

Eligibility highlights

Primary endpoints

•Postprandial Glucose Nadir Following Standardized Test Meals•Plasma Glucose Nadir During the Solid Mixed Meal Tolerance Test•Plasma Glucose Nadir During the Liquid Mixed Meal Tolerance Test

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07878494

Org study ID87775

Timeline

Milestones

Study first posted2026-10-16actual

Last update posted2026-10-16actual

Study start2026-11-01estimated

Primary completion2030-11estimated (month precision)

Study completion2031-11estimated (month precision)

Assets

Investigational agents

Semaglutide Tirzepatide

Who this study enrolls

Prediabetes / glucose intolerance

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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).

Exclusion criteria

•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.

•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).

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Other (unclassified)

Safety / tolerability / PK

Glycemic / diabetes

5 endpoints

Primary/protocol endpoint

Postprandial Glucose Nadir Following Standardized Test Meals

Time frame:During the Diet Arm, approximately 2 to 4 weeks

descriptive

Primary/protocol endpoint

Plasma Glucose Nadir During the Solid Mixed Meal Tolerance Test

Time frame:12 weeks

concentration, descriptive

Primary/protocol endpoint

Plasma Glucose Nadir During the Liquid Mixed Meal Tolerance Test

Time frame:12 weeks

concentration, descriptive

Secondary/protocol endpoint

Postprandial Glucose Peak-to-Nadir Change Measured by CGM

Time frame:12 weeks

descriptive

Secondary/protocol endpoint

Postprandial Insulin Response During the MMTT

Time frame:12 weeks

descriptive

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Hypoglycemia Symptom Severity

Time frame:12 weeks

descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Gastric Emptying Measured by One-Hour Residual Activity

Time frame:12 weeks

descriptive

Secondary/protocol endpoint/low confidence

Postprandial GLP-1 and GIP Responses During the MMTT

Time frame:12 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.