Understanding Non-Alcoholic Fatty Liver Disease in Saudi Patients with Type 2 Diabetes
Non-Alcoholic Fatty Liver Disease in a Saudi Cohort With Type 2 Diabetes Mellitus
King Saud University · NCT05697991
This study looks at how non-alcoholic fatty liver disease affects Saudi adults with type 2 diabetes over 10 years to see how the disease progresses and what factors might make it worse.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | King Saud University (other) |
| Locations | 1 site (Riyadh, Select A State Or Province) |
| Trial ID | NCT05697991 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adult Saudi patients aged 18 to 60 years who have been diagnosed with type 2 diabetes mellitus.
Not a fit: Patients with hepatic decompensation or other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of NAFLD in patients with type 2 diabetes, potentially improving patient outcomes.
How similar studies have performed: While there is accumulating evidence regarding the relationship between NAFLD and metabolic syndrome, this specific cohort study in Saudi patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Riyadh, Select A State Or Province
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nonalcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, T2DM, Fatty Liver Disease, NAFLD