NCT07441447

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

Evaluation of Sarcopenia in Patients With Inflammatory Bowel Disease

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Sakarya University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Crohn Disease (CD)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2025-11-10
• Primary completion: 2026-11-10
• Completion: 2026-12-01
• First posted: 2026-03-02
• Last updated: 2026-03-02

Locations

1 site across 1 country: Turkey (Türkiye)