Status:
NOT_YET_RECRUITING
Impact of Neuropathy on the Risk of Semaglutide-Induced Gastric Retention
Lead Sponsor:
Fudan University
Conditions:
Gastric Retention
Eligibility:
All Genders
18+ years
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...
Detailed Description
Glucagon-like peptide-1 receptor agonists (GLP-1RAs) exert their effects by mimicking the action of endogenous GLP-1, activating GLP-1 receptors located in the pancreas, brain, and gastrointestinal tr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 15 2028
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT07156591
Start Date
September 15 2025
End Date
September 15 2028
Last Update
September 5 2025
Active Locations (1)
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1
Huadong hospital, Fudan university
Shanghai, Shanghai Municipality, China, 200040