Predicting Biologics Success Via VAT AssessmentIBD/VATNCT07126015
Predicting Biologic Therapy Success in Ulcerative Colitis Using Intestinal Ultrasound and Fat Assessment
An observational study of Predicting Biologics Success Via VAT Assessment, run by Assiut University.
Trial summary
Our study aimed to detecting biological therapy effectiveness in UC patients using visceral fat assessment Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Predicting Biologics Success Via VAT Assessment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with ulcerative colitis will undergo detailed medical history (abdominal pain, bloody diarrhea frequency, tenesmus, mucus in stool), anthropometric measurements (weight, height, waist circumference, BMI), and physical examination for fever, tachycardia, abdominal tenderness, and weight loss. Disease activity will be assessed using Montreal classification, Harvey Bradshaw Index (HBI < 5 = remission), and Truelove \& Witts criteria. Visceral adipose tissue volume and distribution will be evaluated by abdominal and pelvic CT examination.
Who may be able to join
- 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.
Who cannot join
- Patients with UC who are under age of 18 years old.
- Pregnancy.
- Previous colectomy.
- Patient refuse to participate in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Predicting Biological Therapy Effectiveness in Ulcerative Colitis Patients Using Intestinal Ultrasound and Visceral Fat Assessment: A Prospective Study
Our study aimed to detecting biological therapy effectiveness in UC patients using visceral fat assessment
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visceral Adipose Tissue Volume Measured by abdominal and pelvic CT examination from Baseline to month 6
Measured: 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
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.
Measured: Baseline (pre-treatment) and after induction dose (typically 6 month post-initiation of biological therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Predicting Biologics Success Via VAT AssessmentStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mohammed Abdel Mowgod, Assiut University
- Investigators
- Amira M Abdelmawgod, Lecturer, Tropical Medicine, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126015
- Sponsor's protocol ID
- 4-2025-300643
- Acronym
- IBD/VAT
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Biological Therapy Effectiveness in Ulcerative Colitis Patients Using Intestinal Ultrasound and Visceral Fat Assessment: A Prospective Study
- ClinicalTrials.gov ID
- NCT07126015
- Acronym / sponsor ID
- IBD/VAT / 4-2025-300643
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with ulcerative colitis will undergo detailed medical history (abdominal pain, bloody diarrhea frequency, tenesmus, mucus in stool), anthropometric measurements (weight, height, waist circumference, BMI), and physical examination for fever, tachycardia, abdominal tenderness, and weight loss. Disease activity will be assessed using Montreal classification, Harvey Bradshaw Index (HBI < 5 = remission), and Truelove \& Witts criteria. Visceral adipose tissue volume and distribution will be evaluated by abdominal and pelvic CT examination.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients with UC who are under age of 18 years old.
- Pregnancy.
- Previous colectomy.
- Patient refuse to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amira M Abdelmawgod, Lecturer, Tropical Medicine principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Predicting Biologics Success Via VAT Assessment, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amira M Abdelmawgod, MD, Assuit University (+201012760437, amiramohmad60@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.