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Not Yet RecruitingNCT07126015

Predicting Biologic Therapy Success in Ulcerative Colitis Using Intestinal Ultrasound and Fat Assessment

Predicting Biological Therapy Effectiveness in Ulcerative Colitis Patients Using Intestinal Ultrasound and Visceral Fat Assessment: A Prospective Study

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
200 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Timeline

Start date
2026-01-01
Primary completion
2026-09-01
Completion
2027-09-01
First posted
2025-08-15
Last updated
2026-01-07

Source: ClinicalTrials.gov record NCT07126015. Inclusion in this directory is not an endorsement.

Predicting Biologic Therapy Success in Ulcerative Colitis Using Intestinal Ultrasound and Fat Assessment (NCT07126015) · Clinical Trials Directory