Evaluation of Sarcopenia in Patients With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Agreement Between Ultrasound and Reference Muscle Measurement
研究概览
简要总结
This prospective observational study aims to evaluate the validity of ultrasonographic muscle measurements in patients with inflammatory bowel disease (IBD). Sarcopenia is commonly assessed using computed tomography (CT)-based skeletal muscle area measurements at the L3 vertebral level, which are considered a gold standard method. However, CT is not always feasible due to radiation exposure and accessibility limitations.
In this study, muscle strength will be assessed using handgrip dynamometry, and muscle mass will be evaluated using ultrasonography of selected skeletal muscles. In patients with available recent abdominal CT imaging, L3 skeletal muscle area will be recorded. The primary objective is to compare ultrasonographic muscle measurements with CT-based assessments and to evaluate the agreement between these methods.
This study aims to determine whether ultrasonography can serve as a practical and reliable alternative tool for muscle mass evaluation in patients with IBD.
详细描述
Inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, is associated with an increased risk of sarcopenia due to chronic systemic inflammation, malnutrition, and treatment-related factors. Accurate assessment of muscle mass is therefore clinically relevant in this population.
Computed tomography (CT)-based skeletal muscle area measurement at the L3 vertebral level is widely accepted as a gold standard for muscle mass assessment. However, CT involves radiation exposure and is not always readily available for repeated evaluation. Ultrasonography (USG) has recently emerged as a promising, non-invasive, radiation-free, and easily accessible method for muscle evaluation, but its validity in patients with IBD requires further investigation.
This single-center, prospective, observational study will enroll adult patients (≥18 years) with a confirmed diagnosis of IBD. Muscle strength will be assessed using handgrip dynamometry. Ultrasonographic measurements will be performed to evaluate thickness and cross-sectional area of selected skeletal muscles, including rectus femoris, vastus intermedius, gastrocnemius medialis, biceps brachii, rectus abdominis, and internal oblique muscles.
For patients with available abdominal CT imaging within the previous six months, skeletal muscle cross-sectional area at the L3 vertebral level will be measured from archived images. The primary outcome of the study is the correlation and agreement between ultrasonographic measurements and CT-based L3 muscle area. Secondary analyses will evaluate associations between muscle measurements, clinical characteristics, and laboratory parameters.
No additional invasive procedures or laboratory tests will be performed for research purposes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Age ≥18 years
- •Established diagnosis of inflammatory bowel disease (ICD-10: K50.* Crohn's disease, K51.* ulcerative colitis)
- •Ability to provide written informed consent
- •Ability to undergo ultrasonographic muscle assessment and handgrip strength testing
- •Availability of an abdominal computed tomography (CT) scan performed within the previous 6 months
排除标准
- •Known neuromuscular disorders or primary muscle diseases
- •Major orthopedic conditions affecting muscle strength assessment
- •Pregnancy
- •Abdominal wall defects or conditions interfering with ultrasound assessment
- •Incomplete clinical or imaging data
- •Any condition preventing reliable ultrasound or handgrip measurement
研究组 & 干预措施
Inflammatory Bowel Disease Cohort
Adult patients with inflammatory bowel disease (ulcerative colitis or Crohn's disease) undergoing evaluation of muscle mass and muscle strength.
干预措施: Muscle Ultrasonography (Diagnostic Test)
结局指标
主要结局
Agreement Between Ultrasound and Reference Muscle Measurement
时间窗: Baseline (at time of assessment)
Agreement and correlation between ultrasound-based muscle measurements and reference (gold-standard) muscle assessment methods in patients with inflammatory bowel disease.
次要结局
- Diagnostic Accuracy of Ultrasound for Detecting Low Muscle Mass Defined by CT-L3(Baseline)
- Association Between Ultrasound Muscle Measurements and Handgrip Strength(Baseline)