Predicting Biological Therapy Effectiveness in Ulcerative Colitis Patients Using Intestinal Ultrasound and Visceral Fat Assessment: A Prospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 200
- Primary Endpoint
- Change in Visceral Adipose Tissue Volume Measured by abdominal and pelvic CT examination from Baseline to month 6
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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)
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Amira Mohammed Abdel Mowgod
Lecturer of Tropical Medicine and Gastroenterology
Assiut University