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

NCT ID: NCT07126015

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-09-01

Brief 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

Predicting Biologics Success Via VAT Assessment

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Amira Mohammed Abdel Mowgod

Lecturer of Tropical Medicine and Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amira M Abdelmawgod, Lecturer, Tropical Medicine

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Amira M Abdelmawgod, MD, Assuit University

Role: CONTACT

amiramohmad60@gmail.com

+201012760437

Other Identifiers

4-2025-300643

Identifier Type: -

Identifier Source: org_study_id