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

NCT ID: NCT05697991

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-23
• Study Completion Date: 2030-12-31

Brief Summary

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.

Detailed Description

The increased prevalence of obesity in both the developed and developing worlds paved the way to 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). It has been estimated that approximately 20% to 30% of the adult population harbors NAFLD. It is also the most common liver pathology among children of developed countries. Unfortunately, despite the alarming figures, NAFLD remains largely underdiagnosed, probably because of its less aggressive nature and benign presentation compared with other liver diseases. Thus, it is apparent that NAFLD, being a precursor to more serious liver conditions such as cirrhosis and hepatocellular carcinoma, should be given equal, if not greater, clinical significance.

Accumulating evidence has pointed to parallel clinical similarities between NAFLD and metabolic syndrome (MetS), the clustering of cardiovascular risk factors with insulin resistance as the common unifying factor. It is well established that persons with MetS are at greater risk of progressing to major chronic non-communicable diseases such as coronary artery disease and type 2 diabetes mellitus (T2DM). Consequently, patients with T2DM are more likely to develop NAFLD. Obesity is acknowledged as one of the common denominators linking NAFLD, MetS, and T2DM, making dietary and lifestyle modifications the gold standard for the treatment of these clinical entities aside from pharmacotherapy that aims to improve insulin sensitivity. Therefore, it is important to better understand the intricate pathophysiology of NAFLD among patients with T2DM so that future interventions will be aimed at reversing complications.

Our current knowledge of NAFLD in terms of prognosis and treatment is promising yet inconclusive, which means that further investigations using prospective approaches are required. Only recently was a consensus design for clinical trials and endpoints for non-alcoholic steatohepatitis (NASH) reported. In this follow-up study, the investigators attempt to decipher the natural history of hepatic steatosis among patients with T2DM using state-of-the-art methods in a well-characterized Saudi cohort. Diabetes, and its related medical complications, have been identified as one of the priority areas of the National Plan for Science and Technology in the Kingdom of Saudi Arabia (KSA).

Conditions

Nonalcoholic Fatty Liver Disease; Type 2 Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Fahad Medical City

OTHER_GOV

Sponsor Role: collaborator

King Saud University

OTHER

Sponsor Role: lead

Responsible Party

Assim Alfadda

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Assim Alfadda, MD

Role: PRINCIPAL_INVESTIGATOR

King Saud University

Locations

King Fahad Medical City

Riyadh, Select A State Or Province, Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

Assim A Alfadda, MD

Role: CONTACT

aalfadda@ksu.edu.sa

0557021171

Rukhsana Gul, MD

Role: CONTACT

Rgul@ksu.edu.sa

0501387295

References

Alfadda AA, Alqutub AN, Sherbeeni SM, Aldosary AS, Alqahtani SA, Isnani A, Gul R, Khaleel MS, Alqasim SM, Almaghamsi AM. Predictors of liver fibrosis progression in cohort of type 2 diabetes mellitus patients with MASLD. J Diabetes Complications. 2025 Feb;39(2):108910. doi: 10.1016/j.jdiacomp.2024.108910. Epub 2024 Nov 20.

Reference Type: DERIVED

PMID: 39675110 (View on PubMed)

Other Identifiers

CORDIAL KSU

Identifier Type: -

Identifier Source: org_study_id