NCT07398222

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2026

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

January 28, 2026

Last Update Submit

February 4, 2026

Conditions

Full Stomach Status

Keywords

gastric ultrasonographytirzepatidefull stomach

Outcome Measures

Primary Outcomes (1)

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

    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.

    1 day

Secondary Outcomes (1)

  • demographic characteristics

    1 day

Study Arms (2)

fasting tirzepatide users

Individuals currently using the medication tirzepatide, who have fasted for at least 8 hours for solids and 2 hours for clear liquids without residues.

Other: Ultrasonographic evaluation of gastric content

fasting volunteers.

Individuals not currently using the medication tirzepatide or any types of GLP-1 analogs, who have fasted for at least 8 hours for solids and 2 hours for clear liquids without residues.

Other: Ultrasonographic evaluation of gastric content

Interventions

Ultrasonographic evaluation of gastric contentOTHER

Ultrasonographic evaluation of gastric content

fasting tirzepatide usersfasting volunteers.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Thirty volunteers will be included, of whom 15 will be current users of tirzepatide and 15 will not be using the medication.

You may qualify if:

  • 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.

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05652900, Brazil

RECRUITING

Study Officials

  • Guilherme F Araujo, MD

    Hospital Israelita Albert Einstein

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guilherme F Araujo, MD

CONTACT

+5511 2151-3729guifreitasaraujo@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 9, 2026

Study Start

January 26, 2026

Primary Completion

March 20, 2026

Study Completion

March 20, 2026

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

BR(1)