NCT Number: NCT07482163
CT Based Assessment of Sarcopenia and Its Association With Biologic Treatment Outcomes in Inflammatory Bowel Disease Patients
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
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year–60 year
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patient above age of 18 years old
- diagnosed to have IBD through: clinical features, endoscopic findings
- received biological therapy
Exclusion criteria
- Patients with UC who are under age of 18 years old.
- Pregnancy.
- Previous colectomy.
- Patient refuse to participate in the study
Treatment and study plan
Primary outcomes
-
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Assiut University
Other
Registry information
Acronym: Sarcopenia/IBD
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Mar 19, 2026
- Registry last updated
- Mar 20, 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.