Investigation of the Evolution of Gastric Emptying by Gastric Ultra Sonography in Patients Treated With GLP-1 Receptor Agonists on a 7 Days Pausing Period.

April 29, 2024 updated by: Eduardo Schiffer, University Hospital, Geneva

Investigation of Gastric Emptying in Patients Treated With GLP-1 Receptor Agonists

Glucagon-like-peptide-1 is a hormone released by the gut enteroendocrine cells. Its secretion occurs after each meal to enable production of insulin and inhibits the production of glucagon to lower after meal glycemia. It also inhibits gastric emptying and food intake. GLP-1 RA plays a role on GLP-1 receptors present on islet beta cells and delta cells of the pancreas to control insulin. GLP-1 receptors are also present in multiple region of the central nervous system such as the hypothalamus and hindbrain where it results in reducing food intake. For anesthesiologist it is important to understand how GLP-1 RA influence gastric emptying. Indeed, respecting a fasting period (6 hours for solid and 2 hours for liquid) before each surgery is one of the cornerstones of anesthesiology to significantly reduce the risk of pulmonary aspiration. One of the side effects of GLP-1 RA is slowing gastric emptying and increasing the risk of regurgitation in patient that observed a recommended fasting period. During 2023 a lot of cases reports have emerged of pulmonary aspiration or the presence of a full stomach in patient treated by GLP-1 RA for a type 2 diabetes. Despite recommendations made by the American Society of Anesthesiology, it is still unkown what is the best fasting period and how long patients should pause a long acting GLP-1 RA before surgery. In this observational study, we would like to determine the effect of GLP-1 RA on gastric emptying in patient scheduled for general anesthesia. We will measure and compare residual gastric content with gastric ultrasonography in patients treated by GLP-1 RA and in those who are not. We will also do these comparisons in a group of patients with type 2 diabetes treated by weekly GLP-1 RA at different days after the injection of the medication. Our hypothesis is that we will observe a reduction in gastric residue in patients who stopped weekly GLP-1 RA 7 days prior the examination compared to those who have stopped less days considering the same fasting period. This would lead us to propose an optimal duration of stopping time for GLP-1 inhibitors in the preoperative period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Detailed Description

The study design consists in a prospective monocentric observational study comparing 2 groups of patients either treated by GLP-1 RA (more than 3 months) or without GLP-1 RA treatment. The investigators will perform a gastric echography, in both groups to define gastric residue after a fasting period of at least 6 hours for solids and 2 hours for liquids. Patients will have free access to any eating regimen before fasting. The instructions given to patients will be to stop eating solids 6h and drinking 2h before investigation. Patients will also fill a nutrition booklet which will be analyzed by a nutritionist nurse thereafter. The investigations will be performed at 24h, 48h, 96h and 144h after last injection of GLP-1 RA in the investigation group, and only once in the control group. Gastric echography will be realized using curved ultrasonic probe placed in sagittal plane on the epigastric area under xyphoid appendix and upper to the umbilicus. Visualization of left hepatic lobe, antrum, aorta and upper mesenteric artery will assess good position of the ultrasonic probe. Qualitative observation of antrum will be made to assess antrum volume in recumbent position. A qualitative and quantitative analyze will be performed in right lateral decubitus by measuring atrum cross-sectional area (CSA). Following formula will be used to determine volume of the antrum : Volume (mL) = 27.0 + 14.6 9 x right-lat CSA - 1.28 x age . A full stomach will be considered when solids are observed or if gastric volume is superior to 1,5 ml/kg. An empty stomach is defined when gastric volume is inferior to 1,5 ml/kg. Gastric echography is proceeded by two anesthetists who will be blinded one to the other. CSA will be compared between two investigation groups. Time-course of CSA and presence of solids or liquids will be assessed at all study time-points up to the seventh day in the investigation group. A reduction of 5,5 cm2 of CSA after one week from last injection of GLP-1 RA will be considered significant. Based on a power study it has been evaluated that a sample of 20 patients per group will be necessary to have a power of 80% with an alpha risk of 0,05.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

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Study Contact

Study Contact

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Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patient with type 2 diabetes treated by an GLP-1 receptors agonists

Description

Inclusion Criteria:

Patients over 18yrs old treated with GLP-1 receptor agonists for at least three months

Exclusion Criteria:

Patients known for gastrointestinal motility disorders, history of gastric surgery, large hiatal hernia, or inability to lie in the right lateral decubitus position.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Non GLP-1 RA group
Patient aged 18 years or older in healthy condition with no gastroparetic treatment and without history of gastro-intestinal pathology, respecting fasting period of 6 hours for solid or thick liquid (juice, milk, sparkling water and soda) and 2 hours for clear liquid (still water, black coffee or tea).
Device: Gastric Ultrasonography
Evaluation of cross sectional area of the antrum by gastric ultrasonography in healthy patients and in patient treated by GLP-1 receptor agonists after a fasting period (6 hours for solid and 2 hours for clear liquids). For the GLP-1 receptor agonists group the gastric ultrasonochography will be repeated each 2 days during 7 days. In the non GLP-1 receptors agonists group the evaluation will be executed one time.
GLP-1 RA group
Patients aged 18 years or older, treated with GLP-1 receptor agonists, respecting fasting period of 6 hours for solid or thick liquid (juice, milk, sparkling water and soda) and 2 hours for clear liquid (still water, black coffee or tea).
Device: Gastric Ultrasonography
Evaluation of cross sectional area of the antrum by gastric ultrasonography in healthy patients and in patient treated by GLP-1 receptor agonists after a fasting period (6 hours for solid and 2 hours for clear liquids). For the GLP-1 receptor agonists group the gastric ultrasonochography will be repeated each 2 days during 7 days. In the non GLP-1 receptors agonists group the evaluation will be executed one time.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change of antral cross sectional area in patients pausing 7 days GLP-1 RA treatment.
Time Frame: 7 days
7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time course of change in gastric volume
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Geneva

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GLP-1 RA patients GE by GUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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