RecruitingNCT05697991

Non-Alcoholic Fatty Liver Disease in a Saudi Cohort With Type 2 Diabetes Mellitus


Sponsor

King Saud University

Enrollment

1,000 participants

Start Date

Mar 23, 2015

Study Type

OBSERVATIONAL

Conditions

Summary

The global rise in the prevalence of obesity paved the way for the increased prevalence of yet another obesity-related complication significant enough to be considered within the roster of major public health threats: non-alcoholic fatty liver disease (NAFLD). In this follow-up study, the investigators will attempt to decipher the natural history of hepatic steatosis among patients with type 2 diabetes mellitus (T2DM) using state-of-the-art methods in a well-characterized Saudi cohort. The investigators aim also to validate existing biomarkers of disease severity and explore the pathogenesis of progressive disease using metabolic profiling technologies. A total of 1000 adult Saudi patients (males and females) with T2DM will be recruited. Those with co-morbidities, including hepatic decompensation, will be excluded. Participants will be followed three times for a total of 10 years/patient (Year 2, Year 5, and Year 10), and measures such as dietary evaluations, anthropometrics, and urine, stool, and blood examinations will be performed. Patients who develop NAFLD will be noted, and patterns/changes in the metabolic profile will be examined. For this specific grant (the first 2 years of the whole project), the investigators will be able to recruit the study cohort, do the baseline anthropometric, imaging, and biochemical measurements, and report the prevalence of NAFLD among patients with T2DM. This information will be the basis of subsequent follow-up and allow for validating potential diagnostic and prognostic biomarkers. This project will be of high importance at the national level since it will create awareness in the local medical community of the current severity status of NAFLD in the kingdom and will be used as a tool to promote public health awareness in the community.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study examines how common non-alcoholic fatty liver disease (a buildup of fat in the liver not caused by alcohol) is among people in Saudi Arabia with type 2 diabetes, and what factors contribute to it. **You may be eligible if...** - You are 18–60 years old - You have type 2 diabetes - You are able to provide informed consent **You may NOT be eligible if...** - You have advanced liver disease (e.g., yellowing skin, fluid in the abdomen, or confusion due to liver failure) - You have liver cancer or another active cancer - You have had a prior heart attack, stroke, bypass surgery, or coronary stent - You have other conditions that would prevent you from safely completing the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

King Fahad Medical City

Riyadh, Select A State Or Province, Saudi Arabia

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NCT05697991


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