NCT07398222 Gastric Content in Fasting Volunteers and in Tirzepatide Users: an Observational and Cross-sectional Study
| NCT ID | NCT07398222 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Israelita Albert Einstein |
| Condition | Full Stomach Status |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-01-26 |
| Primary Completion | 2026-03-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2026-01-26 with a primary completion date of 2026-03-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Guilherme F Araujo, MD
PRINCIPAL INVESTIGATOR
Hospital Israelita Albert Einstein
Frequently Asked Questions
Who can join the NCT07398222 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Full Stomach Status. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07398222 currently recruiting?
Yes, NCT07398222 is actively recruiting participants. Contact the research team at guifreitasaraujo@gmail.com for enrollment information.
Where is the NCT07398222 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07398222 clinical trial?
NCT07398222 is sponsored by Hospital Israelita Albert Einstein. The principal investigator is Guilherme F Araujo, MD at Hospital Israelita Albert Einstein. The trial plans to enroll 30 participants.