Actively Recruiting

Age: 18Years - 60Years
All Genders
NCT05697991

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

Led by King Saud University · Updated on 2023-10-05

1000

Participants Needed

1

Research Sites

823 weeks

Total Duration

On this page

Sponsors

K

King Saud University

Lead Sponsor

K

King Fahad Medical City

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided informed consent before screening
  • Male or female aged 18 to 60 years
  • Diagnosed with type 2 diabetes mellitus (T2DM)
Not Eligible

You will not qualify if you...

  • Signs of liver failure such as ascites or jaundice with bilirubin  40 mol/L
  • Existing liver cancer
  • Any other known liver or non-liver cancer
  • History of heart attack, stroke, or related heart procedures
  • Any condition that may prevent completing the study as judged by the investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

King Fahad Medical City

Riyadh, Select A State Or Province, Saudi Arabia, 11525

Actively Recruiting

Loading map...

Research Team

A

Assim A Alfadda, MD

CONTACT

R

Rukhsana Gul, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here