NCT07172997Active, not recruiting
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
Evaluating Non-Invasive Approaches for Screening, Diagnosis, and Monitoring of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) in Bariatric Patients & Identifying Biomarkers for Predicting Type 2 Diabetes Remission
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
The goal of this observational study is to prospectively develop and validate a non-invasive scoring system based on metabolic markers, proteomic, and transcriptomic profiles to accurately screen, diagnose, stage, and monitor Metabolic dysfunction-associated steatotic liver disease (MASLD) activity and regression as a replacement for the invasive liver biopsy tool in Bahraini bariatric patients. The study also aims to identify biomarkers for predicting type 2 diabetes mellitus remission post-bariatric surgery. The main questions it aims to answer are: * What proteomic and transcriptomic markers can be used to accurately screen, diagnose, stage, and monitor MASLD activity and regression? * What transcriptomic markers can predict type 2 diabetes mellitus remission? Researchers will compare the proteomic and transcriptomic profiles of bariatric patients before and after surgery to identify molecular changes associated with weight loss and normalization of metabolic biomarkers. The data will be used to design and validate a scoring system for MASLD diagnosis and monitoring. Participants will undergo comprehensive assessments, including anthropometric measurements, metabolic biomarker evaluations, proteomic, and transcriptomic profiling at three time points: before surgery, and at 6- and 12-months post-surgery. The data collected will inform the development of the non-invasive scoring system, which will be tested for its reliability and accuracy in replacing liver biopsy as the standard diagnostic tool for MASLD.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 163 (estimated)
- First submitted
- 30 Jan 2025
- Start date
- 1 Jan 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Royal College of Surgeons in Ireland - Medical University of Bahrain
- NCT number
- NCT07172997
What you commit to
- Study type: Observational
- Planned participants: 163
- From 1 Jan 2025 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients fail to complete the surgery due to intra-operative complications.
- Post-liver transplant patients
Other illness
- Patients known to have any liver disease other than MASLD
- Patients with history of Alcohol Drinking.
Other
- Patients fail to retrieve liver biopsy sample from due to intra-operative difficulties.
- Patients with missing data pre-operatively
- Body Mass Index less than 30 kg/m2.
Who the study is looking for
- Adult obese patients undergoing bariatric surgery in KHUH surgery department consented to be included in the study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| King Hamad University Hospital, Coordinator of this site? Confirm its status | Al Muharraq | Bahrain | Unknown status |
| Alhakeem Radiology Center Coordinator of this site? Confirm its status | Manama | Bahrain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.