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NCT Number: NCT07126015

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

Our study aimed to detecting biological therapy effectiveness in UC patients using visceral fat assessment

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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)

    Change in visceral fat volume and distribution as assessed by abdominal and pelvic CT examination before and after the induction phase of biological therapy in patients with ulcerative colitis. CT scans will be analyzed to determine the relationship between VAT and treatment response, considering clinical and endoscopic outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Amira M Abdelmawgod, MD, Assuit University

CONTACT

[email protected]

+201012760437

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: IBD/VAT

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 15, 2025
Registry last updated
Jan 7, 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.