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

NCT05697991 | Recruiting

• 1 other identifier: CORDIAL KSU
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonalcoholic Fatty Liver Disease; Type 2 Diabetes Mellitus

Keywords

T2DM; Fatty Liver Disease; NAFLD

Outcome Measures

Primary Outcomes (1)

• Prevalence of hepatic steatosis in T2DM

  Fatty liver will be assessed by USS and FibroScan in patients with T2DM

  15 years

Secondary Outcomes (2)

• Progression of hepatic steatosis to advanced liver disease will be assessed by USS and FibroScan.

  15 years

• Pathogenesis of progressive disease

  15 years

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population included patients who participated in the Cohort of Non-alcoholic Fatty Liver Disease with T2DM (the CORDIAL Study). This prospective cohort study started in 2015 and recruited patients from King Fahad Medical City (KFMC) and affiliated Primary Care Centers in Riyadh, Saudi Arabia. The patients will be prospectively followed up for 10 years for hepatic, metabolic, renal, and cardiovascular complications.

You may qualify if:

• Subject has provided informed consent prior to screening
• Men and women aged 18 to 60 years
• T2DM

You may not qualify if:

• 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

Sponsors & Collaborators

• King Saud University: lead
• King Fahad Medical City: collaborator

Study Sites (1)

King Fahad Medical City

Riyadh, Select A State Or Province, 11525, Saudi Arabia

RECRUITING

Related Publications (1)

• 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.

  PMID: 39675110 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA, Serum, Urine and Stool

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Assim Alfadda, MD

  King Saud University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Assim A Alfadda, MD

CONTACT

0557021171; aalfadda@ksu.edu.sa

Rukhsana Gul, MD

CONTACT

0501387295; Rgul@ksu.edu.sa

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 26, 2023
• Study Start: March 23, 2015
• Primary Completion (Estimated): April 23, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)