NCT05697991Recruiting
Non-Alcoholic Fatty Liver Disease in a Saudi Cohort With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 5 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 5 Jan 2023
- Start date
- Mar 2015
- Primary completion date
- Apr 2030
- Lead sponsor
- King Saud University
- NCT number
- NCT05697991
What you commit to
- Study type: Observational
- Planned participants: 1000
- From Mar 2015 to the primary completion date, Apr 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Other preexisting hepatic or extrahepatic malignancy
Lab values
- Evidence of hepatic decompensation (ascites, clinical jaundice-bilirubin ≥ 40 µmol/L, encephalopathy)
Other
- Preexisting hepatocellular carcinoma
- Any other issues that, in the opinion of the investigators, may preclude satisfactory completion of the study protocol
Who the study is looking for
- Subject has provided informed consent prior to screening
- Men and women aged 18 to 60 years
- T2DM
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| King Fahad Medical City Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.