Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07441447

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sakarya University Faculty of Medicine, Training and Research Hospital

Sakarya, Adapazarı, 54290, Turkey (Türkiye)

Location status: Recruiting

Location contact

Yunus Günegül, MD

CONTACT

[email protected]

+905386046017

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Agreement Between Ultrasound and Reference Muscle Measurement

    Time frame: 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.

Secondary outcomes

  1. Diagnostic Accuracy of Ultrasound for Detecting Low Muscle Mass Defined by CT-L3

    Time frame: Baseline

    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.

  2. Association Between Ultrasound Muscle Measurements and Handgrip Strength

    Time frame: Baseline

    Association between ultrasound-measured muscle thickness and muscle quality parameters and handgrip strength measurements in patients with inflammatory bowel disease.

Study contacts

Contact information is provided by the study sponsor or research team.

Yunus Günegül

CONTACT

[email protected]

+905386046017

Sponsors and collaborators

Lead sponsor

Sakarya University

Other

Registry information

Official study title

Evaluation of Sarcopenia in Patients With Inflammatory Bowel Disease

Acronym: IBDSARC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.