Gastric RetentionNCT07156591
Impact of Neuropathy on the Risk of Semaglutide-Induced Gastric Retention
An observational study of Gastric Retention, run by Fudan University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Retention
- What is being tested?
- Esophagogastroduodenoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 460 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2025to 15 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Huadong hospital, Fudan university
Shanghai, Shanghai Municipality, 200040
About this study
Official title: Impact of Neuropathy on the Risk of Semaglutide-Induced Gastric Retention: A Single-Center, Prospective, Observational Study
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
Read the 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 tract. On one hand, they promote insulin secretion and suppress glucagon release; on the other, they reduce gastrointestinal motility and delay gastric emptying by stimulating the sympathetic nervous system and inhibiting the parasympathetic nervous system, including enhancing pyloric sphincter contraction. Through these dual mechanisms, GLP-1RAs improve glycemic control and facilitate weight management in patients with type 2 diabetes mellitus (T2DM).
Multiple prior studies and recent meta-analyses have shown that continuous use of GLP-1RAs increases the risk of gastric retention, potentially leading to aspiration and significantly elevating anesthesia-related risk. As a result, several recent expert consensus statements and clinical guidelines-including the 2023 ASA Expert Consensus and the 2025 ASGE Clinical Guidelines-recommend that weekly GLP-1RAs be discontinued for at least one week prior to procedures requiring anesthesia, regardless of dosage. For patients whose discontinuation interval is less than one week, preoperative gastric ultrasound is advised to rule out gastric retention; otherwise, anesthesia should proceed under a "full stomach" protocol.
Given the close connection between GLP-1RA pharmacodynamics and both the autonomic and peripheral nervous systems-and considering that neuropathy is one of the most prevalent complications in T2DM patients-a previous study explored the role of diabetic neuropathy in GLP-1RA-induced delayed gastric emptying. Interestingly, it found that GLP-1RA use in diabetic patients with neuropathy did not significantly slow gastric emptying. However, this study was limited by a small sample size and did not evaluate the actual risk of gastric retention, limiting its clinical relevance.
To further investigate the impact of neuropathy on GLP-1RA-induced gastric retention, we propose a single-center, prospective, observational study. Semaglutide, the most widely used weekly GLP-1RA, will be selected as the study drug. The study will enroll T2DM patients with or without diabetic neuropathy who have been on long-term semaglutide therapy (≥4 weeks) prior to undergoing upper endoscopy. The primary objective is to assess the risk of gastric retention under endoscopic examination.
The findings of this study may contribute to more personalized perioperative management strategies for diabetic patients on semaglutide, potentially reducing anesthesia-related risks while minimizing the glycemic instability associated with prolonged drug discontinuation.
- Conditions
- Gastric Retention
- Being tested
- Esophagogastroduodenoscopy
- Keywords
- Semaglutide, Gastric Retention, Esophagogastroduodenoscopy, Diabetic neuropathy
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsophagogastroduodenoscopyProcedure or surgery
Assess the gastric retention during esophagogastroduodenoscopy
| Study group | Role | What they receive |
|---|---|---|
| Exposure group | Diabetic patients with neuropathy receiving uninterrupted semaglutide therapy Receives: Procedure: Esophagogastroduodenoscopy | |
| Non-exposure group | Diabetic patients without neuropathy receiving uninterrupted semaglutide therapy Receives: Procedure: Esophagogastroduodenoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: immediately after the esophagogastroduodenoscopy
Secondary outcomes (2)
Gastric Mucosal Visibility Score
Measured: immediately after the esophagogastroduodenoscopy
Rate of hypoxemia and aspiration events
Measured: immediately after the esophagogastroduodenoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Sep 2028 (estimated)
- Study completion15 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric RetentionStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijun Bao, Fudan University
- Investigators
- Danian Ji, M.D., Study director, Huadong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156591
- Sponsor's protocol ID
- 2025K249
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Neuropathy on the Risk of Semaglutide-Induced Gastric Retention: A Single-Center, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT07156591
- Acronym / sponsor ID
- 2025K249
- Conditions
- Gastric Retention
- Keywords
- Semaglutide, Gastric Retention, Esophagogastroduodenoscopy, Diabetic neuropathy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Sep 2028 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 tract. On one hand, they promote insulin secretion and suppress glucagon release; on the other, they reduce gastrointestinal motility and delay gastric emptying by stimulating the sympathetic nervous system and inhibiting the parasympathetic nervous system, including enhancing pyloric sphincter contraction. Through these dual mechanisms, GLP-1RAs improve glycemic control and facilitate weight management in patients with type 2 diabetes mellitus (T2DM).
Multiple prior studies and recent meta-analyses have shown that continuous use of GLP-1RAs increases the risk of gastric retention, potentially leading to aspiration and significantly elevating anesthesia-related risk. As a result, several recent expert consensus statements and clinical guidelines-including the 2023 ASA Expert Consensus and the 2025 ASGE Clinical Guidelines-recommend that weekly GLP-1RAs be discontinued for at least one week prior to procedures requiring anesthesia, regardless of dosage. For patients whose discontinuation interval is less than one week, preoperative gastric ultrasound is advised to rule out gastric retention; otherwise, anesthesia should proceed under a "full stomach" protocol.
Given the close connection between GLP-1RA pharmacodynamics and both the autonomic and peripheral nervous systems-and considering that neuropathy is one of the most prevalent complications in T2DM patients-a previous study explored the role of diabetic neuropathy in GLP-1RA-induced delayed gastric emptying. Interestingly, it found that GLP-1RA use in diabetic patients with neuropathy did not significantly slow gastric emptying. However, this study was limited by a small sample size and did not evaluate the actual risk of gastric retention, limiting its clinical relevance.
To further investigate the impact of neuropathy on GLP-1RA-induced gastric retention, we propose a single-center, prospective, observational study. Semaglutide, the most widely used weekly GLP-1RA, will be selected as the study drug. The study will enroll T2DM patients with or without diabetic neuropathy who have been on long-term semaglutide therapy (≥4 weeks) prior to undergoing upper endoscopy. The primary objective is to assess the risk of gastric retention under endoscopic examination.
The findings of this study may contribute to more personalized perioperative management strategies for diabetic patients on semaglutide, potentially reducing anesthesia-related risks while minimizing the glycemic instability associated with prolonged drug discontinuation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure group | – | Procedure: EsophagogastroduodenoscopyDiabetic patients with neuropathy receiving uninterrupted semaglutide therapy |
| Non-exposure group | – | Procedure: EsophagogastroduodenoscopyDiabetic patients without neuropathy receiving uninterrupted semaglutide therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsophagogastroduodenoscopyAssess the gastric retention during esophagogastroduodenoscopy | Procedure or surgery | Exposure group, Non-exposure group |
Primary outcome
Rate of gastric retention
Time frame: immediately after the esophagogastroduodenoscopy
Gastric retention was defined as the presence of solid residues in the stomach or liquid retention exceeding 1.5 mL/kg
2 secondary outcomes
Gastric Mucosal Visibility Score
Time frame: immediately after the esophagogastroduodenoscopy
Rate of hypoxemia and aspiration events
Time frame: immediately after the esophagogastroduodenoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: Yes. All collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Danian Ji, M.D. study director
Huadong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Retention, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danian Ji, M.D. (+86-18019094606, arctg4@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of gastric retention (time frame: immediately after the esophagogastroduodenoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.