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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inflammatory Bowel Disease Cohort | Adult patients with inflammatory bowel disease (ulcerative colitis or Crohn's disease) undergoing evaluation of muscle mass and muscle strength. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Muscle Ultrasonography | Diagnostic Test | Standardized ultrasonographic measurement of skeletal muscle thickness and quality performed in patients with inflammatory bowel disease for comparison with reference muscle assessment methods. |
| Measure | Description | Time Frame |
|---|---|---|
| Agreement Between Ultrasound and Reference Muscle Measurement | Agreement and correlation between ultrasound-based muscle measurements and reference (gold-standard) muscle assessment methods in patients with inflammatory bowel disease. | Baseline (at time of assessment) |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy of Ultrasound for Detecting Low Muscle Mass Defined by CT-L3 | Diagnostic performance of ultrasound-measured muscle thickness and quality for identifying low skeletal muscle mass as defined by CT-derived skeletal muscle index (SMI) at the L3 vertebral level. Area under the receiver operating characteristic curve (AUC), sensitivity, specificity, and optimal cutoff values will be calculated. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis) followed at a tertiary care center and undergoing muscle mass and strength evaluation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunus Günegül | Contact | +905386046017 | yunusgunegul@sakarya.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sakarya University Faculty of Medicine, Training and Research Hospital | Recruiting | Sakarya | Adapazarı | 54290 | Turkey (Türkiye) |
Individual participant data (IPD) that underlie the results reported in this study (after de-identification), including demographic data, laboratory parameters, and outcome measures, will be made available beginning 6 months after publication and ending 5 years after publication.
Data will be shared with researchers who provide a methodologically sound proposal and sign a data access agreement.
Requests should be directed to the corresponding author. The study protocol and statistical analysis plan will also be made available upon reasonable request.
De-identified individual participant data underlying the results reported in this study will be available beginning 6 months after publication of the primary results and ending 5 years after publication.
Data will be made available to researchers who provide a methodologically sound proposal. Proposals will be reviewed by the study investigators. Data access will be granted upon approval and signing of a data use agreement. Only de-identified data will be shared. Requests should be directed to the corresponding author.
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Baseline |
| Association Between Ultrasound Muscle Measurements and Handgrip Strength | Association between ultrasound-measured muscle thickness and muscle quality parameters and handgrip strength measurements in patients with inflammatory bowel disease. | Baseline |
| D007410 | Intestinal Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |