Understanding Non-Alcoholic Fatty Liver Disease in Saudi Patients with Type 2 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the natural history of non-alcoholic fatty liver disease (NAFLD) among a cohort of 1000 Saudi adults with type 2 diabetes mellitus (T2DM). Participants will be followed for a total of 10 years, with evaluations occurring at Year 2, Year 5, and Year 10. The study will utilize advanced metabolic profiling technologies to validate biomarkers of disease severity and explore the pathogenesis of progressive disease. Exclusion criteria include individuals with hepatic decompensation or other significant comorbidities.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subject has provided informed consent prior to screening
* Men and women aged 18 to 60 years
* T2DM

Exclusion Criteria:

* Evidence of hepatic decompensation (ascites, clinical jaundice-bilirubin ≥ 40 µmol/L, encephalopathy)
* Preexisting hepatocellular carcinoma
* Other preexisting hepatic or extrahepatic malignancy
* Previous overt ischemic heart disease (myocardial infarction or acute coronary syndrome) or cerebrovascular disease (stroke or transient ischemic attack)
* Previous coronary artery bypass grafting, angioplasty, or stenting
* Any other issues that, in the opinion of the investigators, may preclude satisfactory completion of the study protocol

Where it's running

• King Fahad Medical City
  Riyadh, Select A State Or Province, Saudi Arabia Recruiting

Study contacts

• Principal investigator: Assim Alfadda, MD — King Saud University
• Study coordinator: Assim A Alfadda, MD
• Email: aalfadda@ksu.edu.sa
• Phone: 0557021171

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.