Clinical trial

Gastric Content in Fasting Volunteers and in Tirzepatide Users: an Observational and Cross-sectional Study

Recruiting now · Not applicable · 1 countries · Registry ID NCT07398222

Recruiting nowNot applicableObservational

What this study is about

Introduction Obesity and type 2 diabetes mellitus constitute a global public health problem. Medications with glucagon-like peptide-1 (GLP-1) receptor agonist activity are a modern therapeutic option for both diseases. Liraglutide, semaglutide, dulaglutide and tirzepatide are representatives of this drug class, whose mechanism of action results in delayed gastric emptying, reduced gastric motility and increased gastric volume. Tirzepatide, however, presents a dual agonist action, combining GLP-1 agonism with glucose-dependent insulinotropic polypeptide (GIP) agonism. The presence of gastric content during anaesthesia may lead to pulmonary aspiration and the development of chemical pneumonitis, a potentially devastating complication. However, when there is a risk factor for delayed gastric emptying, despite adequate fasting, the stomach may still present residual content, and bedside ultrasonography is an effective, non-invasive and rapid method to measure this content and stratify aspiration risk. Our hypothesis is that most individuals using tirzepatide present a full stomach even after fasting times recommended in the literature.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersAccepted
ConditionFull Stomach Status

Full registry criteria

Inclusion Criteria: * Adults aged 18 years or older. * Individuals currently using tirzepatide. * Individuals fasting for at least 8 hours for solids and 2 hours for clear liquids without residue. Exclusion Criteria: * Pregnant or postpartum individuals. * Technical limitation for gastric ultrasound assessment. * Presence of risk factors for gastroparesis. * Use of prokinetic medications such as bromopride, metoclopramide or domperidone.

Treatments and study arms

Ultrasonographic evaluation of gastric content

Other

Ultrasonographic evaluation of gastric content

Primary outcomes

Comparison of the prevalence of a full stomach after fasting using gastric ultrasonography in volunteers using tirzepatide versus those not using the medication.1 day

Comparison of the prevalence of a full stomach after fasting using gastric ultrasonography in volunteers using tirzepatide versus those not using the medication. The outcome is binary: a full stomach is defined as the presence of solids or clear liquid volume greater than 1.5 mL/kg.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Hospital Israelita Albert Einstein🇧🇷 São Paulo, São Paulo, Brazil