Ultrasonographic Evaluation of Gastric Content in Fasting Volunteers and in Tirzepatide Users: an Observational and Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Comparison of the prevalence of a full stomach after fasting using gastric ultrasonography in volunteers using tirzepatide versus those not using the medication.
研究概览
简要总结
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.
详细描述
OBJECTIVES
- Primary objective The primary objective is to evaluate the prevalence of a full stomach through gastric ultrasonography in volunteers who are using tirzepatide and have been fasting for at least 8 hours for solids and 2 hours for clear liquids.
- Secondary objectives The secondary objectives are to evaluate whether the volunteers' demographic characteristics, duration of medication use, time elapsed since the last dose of tirzepatide, dose and dosing regimen, reason for medication use, and the presence of symptoms such as nausea, vomiting, and a sensation of gastric fullness may influence gastric emptying when these individuals are evaluated by ultrasonography.
2. STUDY DESIGN 2.1 Study design Observational, cross-sectional, non-interventional study. Study flowchart Below we present a schematic illustration of the study design.
3. STUDY POPULATION 3.1 Center and population Thirty volunteers will be included in the study, of whom 15 must be currently using tirzepatide and 15 must not be using the medication.
Potential volunteers may be invited in person, such as coworkers, individuals from their social circle, or even patients already referred to the Center for Interventional Medicine for other examinations/procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Ultrasonographic evaluation of gastric content (Other)
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.
干预措施: Ultrasonographic evaluation of gastric content (Other)
结局指标
主要结局
Comparison of the prevalence of a full stomach after fasting using gastric ultrasonography in volunteers using tirzepatide versus those not using the medication.
时间窗: 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.
次要结局
- demographic characteristics(1 day)
研究者
Guilherme Freitas Araujo
MD
Hospital Israelita Albert Einstein