Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers

NCT ID: NCT07172997

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 163 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2027-06-30

Brief Summary

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.

Detailed Description

Metabolic dysfunction Associated Steatotic Liver Disease (MASLD), previously known as NonAlcoholic Fatty Liver Disease (NAFLD), is becoming the most common cause of liver disease in adults with the pandemic of obesity in this century. MASLD is affecting more than quarter of the whole population on earth and the highest prevalence is in the middle east region. A recent retrospective study performed on bariatric patients at the King Hamad University Hospital (KHUH) reported a prevalence of 82.3% of MASLD before the surgery. MASLD progression may lead to liver cirrhosis following which the liver cells become damaged irreversibly. The current gold standard to diagnose MASLD is liver biopsy, however, this method has several limitations due to its invasive nature.

This observational study aims to study MASLD in depth utilizing molecular analysis tools, which can yield more information about disease progression in bariatric patients specific to the Bahraini population.

The total sample size of our study is estimated to be around 163 participants of which 134 subjects would to be positive cases of MASLD. We will include the patients undergoing bariatric surgery from the January to December 2025. An informed consent will be taken from the patients to participate in the research while consenting them for the surgery. The surgeon will inform the participant that radiological and biochemical investigations will be done pre-operatively as well as wedge liver biopsy will be taken during the laparoscopic procedure.

Several data will be collected from the enrolled patients' medical records to study disease progression before the surgery, 6 months and 12 months after the surgery:

1. Anthropometric Measures including weight, hight, body mass index, etc.

2. Body composition data including fat mass, muscle mass, etc.

3. Routine bariatric profile blood results including liver enzymes, platelets, etc.

4. Abdominal ultrasonography reports.

5. Shear wave elastography radiological assessment

6. Proteomic and transcriptomic profiling outside Bahrain

Conditions

MASLD; T2DM (Type 2 Diabetes Mellitus); Non-alcoholic Fatty Liver Disease (NAFLD); Obesity

Study Design

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

Study Groups

MASLD metabolic biomarker

Adult obese patients (18 years old and above) who underwent bariatric surgery in KHUH surgery department from January 2025 to December2025.

Bariatric Surgery

Intervention Type: PROCEDURE

A surgical procedure used to manage obesity and obesity-related conditions.

Interventions

Bariatric Surgery

A surgical procedure used to manage obesity and obesity-related conditions.

Intervention Type: PROCEDURE

Other Intervention Names

Sleeve Gastrectomy; Roux-en-Y; Metabolic Surgery; One Anastomosis Gastric Bypass; Biliopancreatic Diversion; Gastric Bypass; Mini-Bypass; OAGB; SAGB; SG

Eligibility Criteria

Inclusion Criteria

• Adult obese patients undergoing bariatric surgery in KHUH surgery department consented to be included in the study.

Exclusion Criteria

• Patients fail to complete the surgery due to intra-operative complications.
• 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.
• Post-liver transplant patients
• Patients known to have any liver disease other than MASLD
• Patients with history of Alcohol Drinking.

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

Sponsors

King Hamad University Hospital, Bahrain

OTHER

Sponsor Role: collaborator

King Faisal Specialist Hospital & Research Center

OTHER

Sponsor Role: collaborator

King Fahad Medical City

OTHER_GOV

Sponsor Role: collaborator

Royal College of Surgeons in Ireland - Medical University of Bahrain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Flood

Role: PRINCIPAL_INVESTIGATOR

RCSI-MUB

Locations

Alhakeem Radiology Center

Manama, Manama, Bahrain

King Hamad University Hospital

Al Muharraq, Muharraq, Bahrain

Countries

Bahrain

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Other Identifiers

RMS-KHUH /IRB/ 2024-788

Identifier Type: OTHER

Identifier Source: secondary_id

559 / 06-Dec-2024

Identifier Type: -

Identifier Source: org_study_id