Nonalcoholic Fatty Liver DiseaseCORDIALNCT05697991
Non-Alcoholic Fatty Liver Disease in a Saudi Cohort With Type 2 Diabetes Mellitus
An observational study of Nonalcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus, run by King Saud University at 1 site in Saudi Arabia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus
- How many people
- 1,000 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 23 Mar 2015to 31 Dec 2030
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- Subject has provided informed consent prior to screening
- Men and women aged 18 to 60 years
- T2DM
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Fahad Medical City
Riyadh, Select A State Or Province, 11525
About this study
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.
Read the 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).
- Keywords
- T2DM, Fatty Liver Disease, NAFLD
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of hepatic steatosis in T2DM
Fatty liver will be assessed by USS and FibroScan in patients with T2DM
Measured: 15 years
Secondary outcomes (2)
Progression of hepatic steatosis to advanced liver disease will be assessed by USS and FibroScan.
Assessment of hepatic steatosis progression to advanced liver disease by USS and FibroScan.
Measured: 15 years
Pathogenesis of progressive disease
Untargeted metabolomics using a high-throughput proton NMR metabolomics approach for the screening of novel metabolites to understand the pathogenesis of progressive disease
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start23 Mar 2015
- Primary completion23 Apr 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Collaborators
- King Fahad Medical City
- Responsible party
- Principal investigator, Assim Alfadda, King Saud University
- Investigators
- Assim Alfadda, MD, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697991
- Sponsor's protocol ID
- CORDIAL KSU
- Acronym
- CORDIAL
- Status last verified
- Oct 2023
- First submitted
- 5 Jan 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- Individual data sharing
- No: was not including in protocol and consent form
Publications
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.
PubMed 39675110
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Alcoholic Fatty Liver Disease in a Saudi Cohort With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05697991
- Acronym / sponsor ID
- CORDIAL / CORDIAL KSU
- Keywords
- T2DM, Fatty Liver Disease, NAFLD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Collaborators
- King Fahad Medical City
- Study start
- 23 Mar 2015 (actual)
- Primary completion
- 23 Apr 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Subject has provided informed consent prior to screening
- Men and women aged 18 to 60 years
- T2DM
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of hepatic steatosis in T2DM
Time frame: 15 years
Fatty liver will be assessed by USS and FibroScan in patients with T2DM
2 secondary outcomes
Progression of hepatic steatosis to advanced liver disease will be assessed by USS and FibroScan.
Time frame: 15 years
Pathogenesis of progressive disease
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Derived from this study: PubMed 39675110Alfadda 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.
- Individual participant dataSharing planned: No. was not including in protocol and consent form
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Assim Alfadda, MD principal investigator
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonalcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Assim A Alfadda, MD (0557021171, aalfadda@ksu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of hepatic steatosis in T2DM (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05697991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.