Predicting Biologic Therapy Success in Ulcerative Colitis Using Intestinal Ultrasound and Fat Assessment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Predicting Biologics Success Via VAT Assessment. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Predicting Biological Therapy Effectiveness in Ulcerative Colitis Patients Using Intestinal Ultrasound and Visceral Fat Assessment: A Prospective Study
Overview
Our study aimed to detecting biological therapy effectiveness in UC patients using visceral fat assessment
Detailed description
Ulcerative colitis (UC) 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.
Gastrointestinal ultrasound \[GIUS\] has high diagnostic accuracy for detecting active CD, and in trained hands, it can make significant impact on clinical decision-making.
Furthermore, as it is non-invasive, readily available and can be performed bedside, the modality seems well suited for bedside and frequent activity monitoring.
UC is often associated with underweight (BMI \< 18 kg/m2); however, numerous studies find overweight and obesity also common.
Patients were characterized by increased fat deposition and reduced skeletal muscles and theses patients are refractory to IBD treatment may have an increased risk of sarcopenic obesity.
Visceral adipose tissue (VAT) is the white adipose tissue surrounding the viscera, which can be divided into omental adipose tissue, mesenteric adipose tissue (MAT), retroperitoneal fat, peri-gonadal fat, and pericardial fat.
VAT releases inflammatory mediators, such as TNF-α, which are closely associated with inflammation. This suggests that VAT plays an inflammatory role in UC pathogenesis; arguably, VAT is one of the radiological markers.
One research found that VAT is associated with mucosal healing of anti-TNF therapy in Crohn's disease (CD). Studies demonstrated that a higher ratio of visceral to subcutaneous fat (SAT) (VAT:SAT) is linked to a shorter time to IBD flare-ups, including in ulcerative colitis.
Some research indicates that higher VAT levels might be associated with poorer responses to certain IBD treatments, potentially due to the inflammatory environment created by visceral fat.
Primary outcome measures
- Change in Visceral Adipose Tissue Volume Measured by abdominal and pelvic CT examination from Baseline to month 6 [Time frame: Baseline (pre-treatment) and after induction dose (typically 6 month post-initiation of biological therapy) by abdominal and pelvic CT examination]
- Effectiveness of Biological Therapy in UC Patients Based on Changes in Visceral Adipose Tissue (VAT) by abdominal and pelvic CT examination [Time frame: Baseline (pre-treatment) and after induction dose (typically 6 month post-initiation of biological therapy)]
Eligibility criteria
Inclusion criteria
- Any patient above age of 18 years old and diagnosed to have active UC through
- Clinical features: rectal bleeding, with frequent stools and mucous discharge from the rectum. Some patients also describe tenesmus. The onset is typically insidious.
- Endoscopic findings include the following; loss of vascular pattern, Granular and fragile mucosa, friability, ulcerations, erosions, pseudo-polyposis.
Exclusion criteria
- Patients with UC who are under age of 18 years old.
- Pregnancy.
- Previous colectomy.
- Patient refuse to participate in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07126015 · 4-2025-300643