NCT07156591

Brief Summary

A prospective, single-center, observational study to compare the risk of gastric retention between the exposure group (with neuropathy) and non-exposure group (without neuropathy) in diabetic patients receiving uninterrupted semaglutide therapy

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started Sep 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Sep 2025Sep 2028

First Submitted

Initial submission to the registry

August 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2028

Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

3 years

First QC Date

August 28, 2025

Last Update Submit

August 28, 2025

Conditions

Gastric Retention

Keywords

SemaglutideGastric RetentionEsophagogastroduodenoscopyDiabetic neuropathy

Outcome Measures

Primary Outcomes (1)

  • Rate of gastric retention

    Gastric retention was defined as the presence of solid residues in the stomach or liquid retention exceeding 1.5 mL/kg

    immediately after the esophagogastroduodenoscopy

Secondary Outcomes (2)

  • Gastric Mucosal Visibility Score

    immediately after the esophagogastroduodenoscopy

  • Rate of hypoxemia and aspiration events

    immediately after the esophagogastroduodenoscopy

Study Arms (2)

Exposure group

Diabetic patients with neuropathy receiving uninterrupted semaglutide therapy

Procedure: Esophagogastroduodenoscopy

Non-exposure group

Diabetic patients without neuropathy receiving uninterrupted semaglutide therapy

Procedure: Esophagogastroduodenoscopy

Interventions

EsophagogastroduodenoscopyPROCEDURE

Assess the gastric retention during esophagogastroduodenoscopy

Exposure groupNon-exposure group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huadong hospital, Fudan university

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Danian Ji, M.D.

    Huadong Hospital

    STUDY DIRECTOR

Central Study Contacts

Danian Ji, M.D.

CONTACT

+86-18019094606arctg4@163.com

Zhiyu Dong, M.D.

CONTACT

+86-1881787086618817870866@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 28, 2025

First Posted

September 5, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

September 15, 2028

Study Completion (Estimated)

September 15, 2028

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

All collected IPD

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
1 year after completion of this study
Access Criteria
All researchers can require the original data from principal investigator of this study (Email address: arctg4@163.com)

Locations

CN(1)