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

Launched by KING SAUD UNIVERSITY · Jan 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying non-alcoholic fatty liver disease (NAFLD) in people with type 2 diabetes in Saudi Arabia. NAFLD is a condition where fat builds up in the liver without alcohol being the cause, and it has become more common due to rising obesity rates. Researchers want to understand how this disease develops over time in patients with type 2 diabetes and to identify possible markers that can help determine how severe the disease is. They will follow 1,000 adult participants for up to 10 years, checking their diets, body measurements, and conducting various tests to see how many develop NAFLD and how their metabolism changes.

To be eligible for the study, participants must be between 18 and 60 years old and diagnosed with type 2 diabetes. Those with certain liver problems or serious heart issues will not be included. Participants can expect to undergo several assessments over the years, which will help researchers gather important information about NAFLD's impact on health in the local community. This study aims to raise awareness about the seriousness of NAFLD and improve public health strategies in Saudi Arabia.

Gender

ALL

Eligibility criteria

• 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