- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07360262
Gastric Emptying Recovery After GLP-1 RA Cessation
Time-dependent Recovery of Gastric Emptying After Cessation of Glucagon-like Peptide-1 Receptor Agonists: a Prospective Observational Gastric Ultrasound Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study design and setting: This is a prospective observational cohort study conducted at a tertiary academic hospital to evaluate gastric emptying recovery after cessation of GLP-1 receptor agonists. Adult patients (≥18 years) receiving GLP-1 RAs and scheduled for elective surgery under general anesthesia will be enrolled consecutively to minimize selection bias. Prespecified exclusions include prior gastric or esophageal surgery, known gastroparesis, severe gastroesophageal reflux disease, emergency surgery, pregnancy, and inability to provide informed consent.
Exposure (no intervention assignment): The study does not assign or modify GLP-1 RA therapy. Time since the last GLP-1 RA dose will be recorded in days using patient report and medical records and analyzed both as a continuous variable and as prespecified categories (≤3 days, 4-7 days, ≥8 days). Information on GLP-1 RA formulation (weekly vs daily) and dose equivalence may be collected for sensitivity analyses. Potential confounders such as fasting duration and type of surgery will be recorded.
Gastric ultrasound procedures: Point-of-care gastric ultrasound will be performed immediately before induction of anesthesia using a standardized protocol by trained consultant anesthesiologists. The gastric antrum will be assessed in the supine and right lateral decubitus positions. Qualitative assessment of gastric content will be documented, and quantitative measurements of antral cross-sectional area will be used to estimate gastric volume.
Outcomes: The primary outcome is estimated gastric volume normalized to body weight (mL/kg). Secondary outcomes include the presence of a high-risk stomach, as defined by prespecified gastric volume criteria and qualitative ultrasound findings. Additional exploratory analyses will evaluate whether body mass index modifies the association between cessation interval and gastric volume and whether patient-reported gastrointestinal symptoms correlate with ultrasound findings.
Analysis overview: Associations between time since the last GLP-1 RA dose and gastric ultrasound outcomes will be assessed using prespecified regression models adjusted for relevant covariates (e.g., age, sex, BMI, diabetes status, fasting duration, and symptom measures). The interaction between BMI and cessation interval will be evaluated to characterize potential effect modification.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Jeollabuk-do
-
Iksan, Jeollabuk-do, South Korea, 54538
- Wonkwang University Hospital
-
Iksan, Jeollabuk-do, South Korea, 54538
- Wonkwang University School of Medicine Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria
- Adults aged ≥18 years
- Receiving a glucagon-like peptide-1 receptor agonist (GLP-1 RA)
- Scheduled for elective surgery under general anesthesia
- Able to provide written informed consent
Exclusion Criteria
- Prior gastric or esophageal surgery
- Known gastroparesis
- Severe gastroesophageal reflux disease
- Emergency surgery
- Pregnancy
- Inability to provide informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
GLP-1 RA cessation ≤3 days
Participants using GLP-1 receptor agonists whose last dose was taken ≤3 days before the preoperative gastric ultrasound assessment (performed immediately prior to induction of anesthesia).
|
Preoperative point-of-care gastric ultrasound was performed immediately prior to induction of anesthesia to assess qualitative gastric content and to estimate gastric volume from antral cross-sectional area.
The procedure was observational and was applied to all cohorts; no study-assigned treatment was administered or modified.
Other Names:
|
|
GLP-1 RA cessation 4-7 days
Participants using GLP-1 receptor agonists whose last dose was taken 4-7 days before the preoperative gastric ultrasound assessment (performed immediately prior to induction of anesthesia).
|
Preoperative point-of-care gastric ultrasound was performed immediately prior to induction of anesthesia to assess qualitative gastric content and to estimate gastric volume from antral cross-sectional area.
The procedure was observational and was applied to all cohorts; no study-assigned treatment was administered or modified.
Other Names:
|
|
GLP-1 RA cessation ≥8 days
Participants using GLP-1 receptor agonists whose last dose was taken ≥8 days before the preoperative gastric ultrasound assessment (performed immediately prior to induction of anesthesia).
|
Preoperative point-of-care gastric ultrasound was performed immediately prior to induction of anesthesia to assess qualitative gastric content and to estimate gastric volume from antral cross-sectional area.
The procedure was observational and was applied to all cohorts; no study-assigned treatment was administered or modified.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ultrasound-estimated gastric volume (mL/kg)
Time Frame: Immediately preoperatively (just before induction of anesthesia)
|
Estimated gastric volume normalized to body weight (mL/kg) was calculated from the gastric antral cross-sectional area measured by preoperative point-of-care ultrasound using validated equations.
|
Immediately preoperatively (just before induction of anesthesia)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perlas grade of gastric content (0-2)
Time Frame: Immediately preoperatively (just before induction of anesthesia)
|
Qualitative gastric ultrasound grading of gastric content was recorded using the Perlas classification (Grade 0, 1, or 2) based on antral appearance in the supine and right lateral decubitus positions.
|
Immediately preoperatively (just before induction of anesthesia)
|
|
Antral cross-sectional area (CSA, cm²)
Time Frame: Immediately preoperatively (just before induction of anesthesia)
|
Gastric antral cross-sectional area (cm²) was measured by preoperative ultrasound and used to estimate gastric volume.
|
Immediately preoperatively (just before induction of anesthesia)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cheol Lee, M.D.,Ph.D, Wonkwang University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Wonkwang UH 23
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastroparesis
-
Johns Hopkins UniversityCompletedDiabetic Gastroparesis | Idiopathic Gastroparesis | Gastroparesis PostoperativeUnited States
-
Northern Jiangsu People's HospitalRecruitingDiabetic GastroparesisChina
-
Johns Hopkins Bloomberg School of Public HealthNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedGastroparesis | Diabetic Gastroparesis | Idiopathic GastroparesisUnited States
-
Vanda PharmaceuticalsRecruitingGastroparesis | Diabetic Gastroparesis | Idiopathic GastroparesisBelgium, Germany
-
Neurogastrx, Inc.CompletedDiabetic Gastroparesis | Idiopathic GastroparesisUnited States
-
Vanda PharmaceuticalsCompletedGastroparesis | Diabetic Gastroparesis | Idiopathic GastroparesisUnited States
-
Texas Tech University Health Sciences Center, El...CompletedDiabetic Gastroparesis | Idiopathic GastroparesisUnited States
-
TakedaCompletedDiabetic Gastroparesis | Idiopathic GastroparesisUnited States
-
Evangelic Hospital Kalk CologneEnterra Medical, Inc.RecruitingGastroparesis | Gastroparesis Postoperative | Gastroparesis With Diabetes Mellitus | Gastroparesis NondiabeticGermany
-
The Cleveland ClinicActive, not recruitingGastroparesis Like SymptomsUnited States
Clinical Trials on Preoperative gastric ultrasound
-
Kocaeli UniversityNot yet recruitingDiabetes Mellitus | Gastric Volume | Preoperative FastingTurkey (Türkiye)
-
Hôpital Necker-Enfants MaladesUnknownGastric Content | Full Stomach StatusFrance
-
Samuel Lunenfeld Research Institute, Mount Sinai...CompletedPregnancy | Respiratory Aspiration of Gastric ContentCanada
-
Hospices Civils de LyonCompleted
-
Medical University of South CarolinaRecruiting
-
Tanta UniversityRecruitingDiabetes Mellitus | Elective Surgery | Gastric UltrasoundEgypt
-
Columbia UniversityRecruiting
-
Centre Hospitalier Universitaire DijonCompletedIntensive Care | ExtubationFrance
-
Kahramanmaras Sutcu Imam UniversityCompleted
-
Prince of Wales Hospital, Shatin, Hong KongCompleted