CT Based Assessment of Sarcopenia and Its Association With Biologic Treatment Outcomes in Inflammatory Bowel Disease Patients (Sarcopenia/IBD)

March 18, 2026 updated by: Amira Mohammed Abdel Mowgod, Assiut University
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

Study Overview

Status

Not yet recruiting

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At base line

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 04-2026-300823

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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