Идёт набор NCT07441447

Evaluation of Muscle Strength and Muscle Mass in Patients With Inflammatory Bowel Disease

— Наблюдательное Crohn Disease (CD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Muscle Ultrasonography.
Кому может быть актуально: Состояния в реестре: Crohn Disease (CD). Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Turkey (Türkiye)
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Evaluation of Sarcopenia in Patients With Inflammatory Bowel Disease

Обзор

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.

Подробное описание

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.

Вмешательства

Диагностический тест Muscle Ultrasonography
Standardized ultrasonographic measurement of skeletal muscle thickness and quality performed in patients with inflammatory bowel disease for comparison with reference muscle assessment methods.

Первичные конечные точки

Agreement Between Ultrasound and Reference Muscle Measurement [Срок оценки: Baseline (at time of assessment)]

Вторичные конечные точки (2)

Diagnostic Accuracy of Ultrasound for Detecting Low Muscle Mass Defined by CT-L3 [Срок оценки: Baseline]
Association Between Ultrasound Muscle Measurements and Handgrip Strength [Срок оценки: Baseline]

Критерии участия

Критерии включения

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