Crohn Disease (CD)IBDSARCNCT07441447
Evaluation of Muscle Strength and Muscle Mass in Patients With Inflammatory Bowel Disease
An observational study of Crohn Disease (CD), run by Sakarya University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease (CD)
- What is being tested?
- Muscle Ultrasonography
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sakarya University Faculty of Medicine, Training and Research Hospital
Sakarya, Adapazarı, 54290
Yunus Günegül, MD, +905386046017, yunusgunegul@sakarya.edu.tr
About this study
Official title: Evaluation of Sarcopenia 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.
Read the 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)
- Being tested
- Muscle Ultrasonography
- Keywords
- Sarcopenia, Muscle Ultrasound, Computed Tomography, Handgrip Strength, L3 Skeletal Muscle
- Medical subject headings
- Crohn Disease, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle UltrasonographyDiagnostic test
Standardized ultrasonographic measurement of skeletal muscle thickness and quality performed in patients with inflammatory bowel disease for comparison with reference muscle assessment methods.
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory Bowel Disease Cohort | Adult patients with inflammatory bowel disease (ulcerative colitis or Crohn's disease) undergoing evaluation of muscle mass and muscle strength. Receives: Diagnostic Test: Muscle Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (at time of assessment)
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start10 Nov 2025
- Primary completion10 Nov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441447
- Sponsor's protocol ID
- E523224-2025
- Acronym
- IBDSARC
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sarcopenia in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT07441447
- Acronym / sponsor ID
- IBDSARC / E523224-2025
- Conditions
- Crohn Disease (CD)
- Keywords
- Sarcopenia, Muscle Ultrasound, Computed Tomography, Handgrip Strength, L3 Skeletal Muscle
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inflammatory Bowel Disease Cohort | – | Diagnostic Test: Muscle UltrasonographyAdult patients with inflammatory bowel disease (ulcerative colitis or Crohn's disease) undergoing evaluation of muscle mass and muscle strength. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle UltrasonographyStandardized ultrasonographic measurement of skeletal muscle thickness and quality performed in patients with inflammatory bowel disease for comparison with reference muscle assessment methods. | Diagnostic test | Inflammatory Bowel Disease Cohort |
Primary outcome
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.
2 secondary outcomes
Diagnostic Accuracy of Ultrasound for Detecting Low Muscle Mass Defined by CT-L3
Time frame: Baseline
Association Between Ultrasound Muscle Measurements and Handgrip Strength
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease (CD), run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunus Günegül (+905386046017, yunusgunegul@sakarya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Between Ultrasound and Reference Muscle Measurement (time frame: Baseline (at time of assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.