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

NCT07441447 | Recruiting

• 1 other identifier: E523224-2025
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn Disease (CD)

Keywords

Sarcopenia; Muscle Ultrasound; Computed Tomography; Handgrip Strength; L3 Skeletal Muscle

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

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

  Baseline

• Association Between Ultrasound Muscle Measurements and Handgrip Strength

  Baseline

Study Arms (1)

Inflammatory Bowel Disease Cohort

Adult patients with inflammatory bowel disease (ulcerative colitis or Crohn's disease) undergoing evaluation of muscle mass and muscle strength.

Diagnostic Test: Muscle Ultrasonography

Interventions

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.

Inflammatory Bowel Disease Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya University Faculty of Medicine, Training and Research Hospital

Sakarya, Adapazarı, 54290, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Sarcopenia

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Yunus Günegül

CONTACT

+905386046017; yunusgunegul@sakarya.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 2, 2026
• Study Start: November 10, 2025
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: 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.

Locations

TU (1)