CT-Assessed Sarcopenia OutcomesSarcopenia/IBDNCT07482163
CT Based Assessment of Sarcopenia and Its Association With Biologic Treatment Outcomes in Inflammatory Bowel Disease Patients
An observational study of CT-Assessed Sarcopenia Outcomes, run by Assiut University.
Trial summary
Our study aims to investigate the incidence of sarcopenia in Patients with IBD using CT-based body composition parameters, observe the interaction between sarcopenia and IBD treatment, and determine whether sarcopenia affects the response to biologic therapies Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- CT-Assessed Sarcopenia Outcomes
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 May 2028
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: * Thorough medical history, anthropometric measurements (weight, height, waist circumference, BMI), and physical examination (general and abdominal) stressing on significant weight loss. * Laboratory investigations (Complete blood picture, Liver function tests, C-reactive protein and ESR, Fecal calprotectin) and colonoscopy will done with assessment of severity . * CT examination will performed following the standard imaging protocol. At the level of the third lumbar vertebra, the boundaries of skeletal muscles were manually outlined using Image J software version 1.54p. Throughout the study, the boundaries of skeletal muscles were determined by trained radiologists. Pre-defined radiation attenuation ranges are used to demarcate muscle (-29 Hounsfield units to +150 Hounsfield units). Calculate the skeletal muscle area (SMA) in square centimeters from the pixel count using ImageJ.
Who may be able to join
- Patient above age of 18 years old
- diagnosed to have IBD through: clinical features, endoscopic findings
- received biological therapy
Who cannot join
- Patients with UC who are under age of 18 years old.
- Pregnancy.
- Previous colectomy.
- Patient refuse to participate in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Our study aims to investigate the incidence of sarcopenia in Patients with IBD using CT-based body composition parameters, observe the interaction between sarcopenia and IBD treatment, and determine whether sarcopenia affects the response to biologic therapies
Read the detailed description
Inflammatory bowel disease (IBD) has a relapsing-remitting course which necessitates frequent follow-up examinations to monitor disease activity.
Disease management was previously guided by patient reported symptoms, and treatment targets were based on symptom control. However, the patient's symptoms do not necessarily correspond to inflammatory activity and current guidelines recommend that management should be based on objective evaluations.
Due to reduced food intake, intestinal malabsorption, chronic protein loss through the feces, and increased energy demands from hypermetabolism , patients with IBD may suffer from malnutrition, and sarcopenia, even during remission. In 2014, the Asian Working Group forSarcopenia defined sarcopenia as an age-related decline in skeletal muscle mass as well as muscle function (defined by muscle strength or physical performance).
Sarcopenia has been associated with older age, but it is also a known complication of various chronic diseases, such as cirrhosis, intestinal disorders, chronic kidney disease, neurodegenerative diseases, and malignant tumors . Sarcopenia affects the prognosis of IBD and is recognized as a risk factor for surgery, hospitalization, and postoperative complications in patients with IBD.
Skeletal muscle mass can be assessed using various methods, including bioelectrical impedance analysis (BIA) , dual-energy X-ray absorptiometry (DXA), computed tomography (CT), and magnetic resonance imaging (MRI). However each technique exhibits considerable variability and lacks established reference standards. The total skeletal muscle area measured by CT or MRI at the L3-L4 lumbar spine levels is regarded as the gold standard for assessing skeletal muscle mass. CT enterography (CTE) is a routine diagnostic procedure for and can be utilized to evaluate their skeletal muscle mass without the need for additional tests.
- Conditions
- CT-Assessed Sarcopenia Outcomes
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Sarcopenia in Inflammatory Bowel Disease Patients
To determine the incidence of sarcopenia in patients with inflammatory bowel disease using computed tomography (CT)-based body composition analysis, including skeletal muscle index (SMI) measured at the level of the third lumbar vertebra (L3), expressed in cm²/m².
Measured: At base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CT-Assessed Sarcopenia OutcomesStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mohammed Abdel Mowgod, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482163
- Sponsor's protocol ID
- 04-2026-300823
- Acronym
- Sarcopenia/IBD
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Based Assessment of Sarcopenia and Its Association With Biologic Treatment Outcomes in Inflammatory Bowel Disease Patients
- ClinicalTrials.gov ID
- NCT07482163
- Acronym / sponsor ID
- Sarcopenia/IBD / 04-2026-300823
- Conditions
- CT-Assessed Sarcopenia Outcomes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 19 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.
Our study aims to investigate the incidence of sarcopenia in Patients with IBD using CT-based body composition parameters, observe the interaction between sarcopenia and IBD treatment, and determine whether sarcopenia affects the response to biologic therapies
Detailed description
Inflammatory bowel disease (IBD) has a relapsing-remitting course which necessitates frequent follow-up examinations to monitor disease activity.
Disease management was previously guided by patient reported symptoms, and treatment targets were based on symptom control. However, the patient's symptoms do not necessarily correspond to inflammatory activity and current guidelines recommend that management should be based on objective evaluations.
Due to reduced food intake, intestinal malabsorption, chronic protein loss through the feces, and increased energy demands from hypermetabolism , patients with IBD may suffer from malnutrition, and sarcopenia, even during remission. In 2014, the Asian Working Group forSarcopenia defined sarcopenia as an age-related decline in skeletal muscle mass as well as muscle function (defined by muscle strength or physical performance).
Sarcopenia has been associated with older age, but it is also a known complication of various chronic diseases, such as cirrhosis, intestinal disorders, chronic kidney disease, neurodegenerative diseases, and malignant tumors . Sarcopenia affects the prognosis of IBD and is recognized as a risk factor for surgery, hospitalization, and postoperative complications in patients with IBD.
Skeletal muscle mass can be assessed using various methods, including bioelectrical impedance analysis (BIA) , dual-energy X-ray absorptiometry (DXA), computed tomography (CT), and magnetic resonance imaging (MRI). However each technique exhibits considerable variability and lacks established reference standards. The total skeletal muscle area measured by CT or MRI at the L3-L4 lumbar spine levels is regarded as the gold standard for assessing skeletal muscle mass. CT enterography (CTE) is a routine diagnostic procedure for and can be utilized to evaluate their skeletal muscle mass without the need for additional tests.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * Thorough medical history, anthropometric measurements (weight, height, waist circumference, BMI), and physical examination (general and abdominal) stressing on significant weight loss. * Laboratory investigations (Complete blood picture, Liver function tests, C-reactive protein and ESR, Fecal calprotectin) and colonoscopy will done with assessment of severity . * CT examination will performed following the standard imaging protocol. At the level of the third lumbar vertebra, the boundaries of skeletal muscles were manually outlined using Image J software version 1.54p. Throughout the study, the boundaries of skeletal muscles were determined by trained radiologists. Pre-defined radiation attenuation ranges are used to demarcate muscle (-29 Hounsfield units to +150 Hounsfield units). Calculate the skeletal muscle area (SMA) in square centimeters from the pixel count using ImageJ.
Key inclusion criteria (3 listed)
- Patient above age of 18 years old
- diagnosed to have IBD through: clinical features, endoscopic findings
- received biological therapy
Key exclusion criteria (4 listed)
- Patients with UC who are under age of 18 years old.
- Pregnancy.
- Previous colectomy.
- Patient refuse to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Sarcopenia in Inflammatory Bowel Disease Patients
Time frame: At base line
To determine the incidence of sarcopenia in patients with inflammatory bowel disease using computed tomography (CT)-based body composition analysis, including skeletal muscle index (SMI) measured at the level of the third lumbar vertebra (L3), expressed in cm²/m².
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 Nov 2026.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of CT-Assessed Sarcopenia Outcomes, run by Assiut University.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Amira M. Abdelmawgod, MD, Assuit University (+201012760437, amiramohmad60@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Sarcopenia in Inflammatory Bowel Disease Patients (time frame: At base line). 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 Nov 2026.