Not yet recruiting

Impact of Neuropathy on the Risk of Semaglutide-Induced Gastric Retention

Impact of Neuropathy on the Risk of Semaglutide-Induced Gastric Retention: A Single-Center, Prospective, Observational Study

Lead sponsor

Fudan University

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

460

Study population

Diabetes (other / unspecified), Diabetic neuropathy, Perioperative / gastric aspiration risk

Eligibility highlights

Primary endpoint

•Gastric retention

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 IDNCT07156591

Org study ID2025K249

Timeline

Milestones

Study first posted2025-09-05actual

Last update posted2025-09-05actual

Study start2025-09-15estimated

Primary completion2028-09-15estimated

Study completion2028-09-15estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Diabetes (other / unspecified)Diabetic neuropathyPerioperative / gastric aspiration risk

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Sampling methodProbability sample

Study population text

Diabetic patients undergoing esophagogastroduodenoscopy who have been on long-term semaglutide therapy (≥4 weeks), either with neuropathy (exposure group) or without neuropathy (non-exposure group).

Inclusion criteria

•Confirmed diagnosis of diabetes mellitus.

•Long-term use of semaglutide (for at least 4 weeks) without discontinuation prior to endoscopic examination.

•Age ≥ 18 years, with no restriction on sex.

•American Society of Anesthesiologists (ASA) physical status classification I-II.

•Fasting for at least 8 hours and no water intake for at least 4 hours prior to gastroscopy.

•Underwent assessment for both autonomic and peripheral neuropathy within 2 weeks prior to gastroscopy, with a clear determination of neuropathy status.

Exclusion criteria

•History of hiatal hernia or any prior gastric surgery (including gastrectomy, Roux-en-Y gastric bypass, etc.).

•Pregnancy.

•Medically unfit for gastrointestinal endoscopy.

•Deemed unsuitable for participation at the discretion of the investigators.

Endpoints (3)

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

Other clinical outcomes

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Rate of hypoxemia and aspiration events

Time frame:immediately after the esophagogastroduodenoscopy

event count, event

componentshypoxemia event, aspiration event

Other clinical outcomes

2 endpoints

Primary/protocol endpoint

Rate of gastric retention

Time frame:immediately after the esophagogastroduodenoscopy

categorical status, improvement

Secondary/protocol endpoint

Gastric Mucosal Visibility Score

Time frame:immediately after the esophagogastroduodenoscopy

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 July 6, 2026 snapshot.