Following fatty liver disease in Saudi adults with type 2 diabetes over time

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 60 with type 2 diabetes (T2DM). It studies fatty liver disease in this group.

Age

18 to 60 years

Sex

Men and women

Disease stage

Type 2 diabetes (T2DM). Signs of liver failure (hepatic decompensation) are not allowed.

Main reasons for not taking part

• Signs of liver failure: ascites, clinical jaundice (bilirubin ≥ 40 µmol/L), encephalopathy
• Liver cancer (hepatocellular carcinoma) or any other liver or non-liver cancer already present
• Previous heart attack, acute coronary syndrome, stroke or transient ischemic attack
• Previous coronary artery bypass surgery, angioplasty or stenting
• Any other issue that the investigators think would stop the person from completing the study

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 60 years old?YesNo

What the trial wants to find out

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.