- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07506356
Investigation of Gastric Emptying by Gastric Ultrasonography in Diabetic Patients Treated With GLP-1 Receptors (SAGUSE)
Investigation of Gastric Emptying by Gastric Ultrasonography in Diabetic Patients Treated With GLP-1 Receptors Agonists
Treatment with semaglutide slows down gastric emptying , food remains in the stomach for a longer period of time. This slowing has important implications for anesthesia management. At present, we do not know the optimal duration for discontinuing this medication before surgery and anesthesia to ensure an empty stomach.
This is an observational research project, conducted exclusively at the Geneva University Hospitals (HUG). To answer the research question, participation of 38 individuals will be required. The duration of participation for each person is 7 days.
To recruit the necessary number of participants, approximately 1.5 years will be needed.
This project is being carried out in accordance with Swiss legal requirements and recognized international guidelines. The competent ethics committee has reviewed and approved this project.
The project will last 7 day during which the participants will need to come 3 times at the hospital to make gastric ultrasounds. On these days the participants will be asked to have a breakfast between 7 and 8 am including a minimum of bread and/or cereals and/or proteins. After that the participants will be asked to fast for 6 hours for solide food and 2 hours for liquids. If the participants smokes, they must for 12h before the exam.
At 2Pm an anesthesiologist will welcome the participant to make the exam at the hospital to evaluate the gastric volume after what the participants will be able to get a small collation and go back home.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Canton of Geneva
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Geneva, Canton of Geneva, Switzerland, 1211
- Recruiting
- Hôpitaux Universitaires de Genève
-
Contact:
- Rey-Millet Quentin RMQuentin Dr
- Phone Number: +4179.55.380.54
- Email: quentin.rey-millet@hug.ch
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Principal Investigator:
- Rey-Millet RMQuentin Quentin, Dr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Female/ Male of 18 years old or more
- With Type 2 Diabetes
- Treated with GLP 1 analog for more than 3 months
- Signed consent
- ASA between I and IV
Exclusion Criteria:
- Insuline treatment
- Gastro intestinal motility disorders
- Past gastric surgery
- Hiatal hernia
- Recent trauma
- Inability to be lay down for the exam
- Inability to follow the instructions for the exam (language, dementia)
- BMI > 40
- Inability to stop smoking 12h before the measures
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Diabetic patients under GLP-1 receptors agonists
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
A safe gastric volume for anesthesia in diabetic patients treated with GLP-1 analog after a 6 hours fasting period 7 day after the last injection.
Time Frame: 1 week
|
Our primary objective is to show that after a fasting period of 6 hours, seven days after the last injection of GLP-1, gastric volume of diabetic patients is safe for anaesthesia.
Our hypothesis is that seven days after the last injection of GLP-1, and after a 6h fasting period, the mean gastric volume of treated patients will be lower than 1.5 ml/kg, corresponding to the most accepted volume threshold of an at risk (full) stomach
|
1 week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Metabolic Diseases
- Digestive System Diseases
- Gastrointestinal Diseases
- Glucose Metabolism Disorders
- Esophageal Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Nutritional and Metabolic Diseases
- Diabetes Mellitus, Type 2
- Diabetes Mellitus
- Gastroesophageal Reflux
Other Study ID Numbers
- 2025-01341
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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