MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)NCT07548970
Identification and Characterization of At-risk MASLD in Turkish Adults
An observational study of MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease) and Mediterranean Diet, run by Maastricht University Medical Center at 1 site in Turkey (Türkiye).
Trial summary
MASLD is with 25% the most prevalent liver disorder in Western society and is associated with overweight, obesity, metabolic syndrome (MetS), type 2 diabetes mellitus (T2DM) and cardiovascular diseases (CVD). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), Mediterranean Diet, Lifestyle (Sedentary Behavior and Physical Activity)
- How many people
- 459 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 459 male and female participants aged between 18-80, who can sign the informed consent and are eligible to participate.
Who may be able to join
- One of the following conditions:
- BMI ≥ 25 kg/m2 OR WC> 94 cm (M) 80 cm (F)
- Fasting serum glucose ≥ 100 mg/dL OR 2-hour post-load glucose levels ≥140 mg/dL OR HbA1c ≥ 5.7% OR type 2 diabetes OR treatment for type 2 diabetes
- Blood pressure ≥ 130/85 mmHg OR specific antihypertensive drug treatment
- Plasma triglycerides ≥ 150 mg/dL OR lipid lowering treatment
- Plasma HDL-cholesterol ≤40 mg/dL (Male) and ≤ 50 mg/dL (Female) OR lipid lowering treatment
Who cannot join
- Excessive alcohol use (more than 20 g/day for women and 30g/day for men= >2 glasses alcohol/day for women and >3 glasses for men)
- Hepatitis B virus,
- Hepatitis C virus,
- Autoimmune hepatitis,
- Primary biliary cirrhosis,
- Hemochromatosis,
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- Wilson's disease,
- Alpha 1 antitrypsin deficiency
- HCV Genotype 3,
- Total parental nutrition,
- Current use of hepatotoxic medications (amiodarone, tamoxifen, methotrexate, corticosteroids and HAART),
- Celiac disease,
- Pregnancy and breastfeeding
- A history of bariatric surgery
- Current diagnosis of liver cirrhosis and/or hepatocellular carcinoma.
- Current diagnosis of extrahepatic malignancy(s) or prior diagnosis within last 5 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification and Characterization of Metabolic Dysfunction-Associated Steatotic Liver Disease Among Risk Groups in Turkey
MASLD is with 25% the most prevalent liver disorder in Western society and is associated with overweight, obesity, metabolic syndrome (MetS), type 2 diabetes mellitus (T2DM) and cardiovascular diseases (CVD). MASLD is defined by a hepatic fat accumulation of more than 5% in the absence of classical causes of steatogenesis (e.g. alcohol and steatogenic drugs). It represents a broad spectrum of clinical entities from steatosis to advanced liver disease with hepatic failure. Most of the patients have simple steatosis, however in about 15-30% steatohepatitis (MASH) develops, which leads to an overall increase in morbidity and mortality due to the progression to fibrosis, cirrhosis and hepatocellular carcinoma (HCC). Patients with MASLD have no or few, mainly specific symptoms; and generally there is a silent progression of simple steatosis to NASH and in the end liver-related morbidity and mortality. Despite the clinical importance and the potential impact on healthcare resources, the majority of MASLD patients are currently not detected due to the lack of non-invasive methods to diagnose MASLD. To date, the prevalance of MASLD in Turkey among subjects at risk, and its relation to common comorbidities such as obesity, T2DM and CVD is not clear. Therefore, identification of MASLD patients in this cohort will give information on the prevalence in the group of uncomplicated overweight and obesity and those with concomitant cardiometabolic diseases. By early detecting these patients at risk to develop progressive liver diseases and extrahepatic manifestations, it will be possible to intervene and improve health. Within this context, this study aims to detect prevalence of MASLD among risk groups. Also, the risk factors related to MASLD etiology and progression, such as overweight, obesity, T2DM, CVD, diet and physical activity will be studied to have a better understanding of their presumed causal relationship with MASLD.
This study is designed to study the prevalence of and risk factors associated with MASLD in adult populations at-risk of MASLD. Participants will undergo liver assessments via vibration controlled transient elastography. Lifestyle, demographic, and biochemical data will be collected.
- Conditions
- MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), Mediterranean Diet, Lifestyle (Sedentary Behavior and Physical Activity), Vitamin D Deficiency, Hyperuricemia and MAFLD, Ferritin
- Keywords
- MASLD
- Medical subject headings
- Sedentary Behavior, Motor Activity, Vitamin D Deficiency, Hyperuricemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Proportion of participants with hepatic steatosis defined by controlled attenuation parameter (CAP ≥248 dB/m) measured using vibration-controlled transient elastography
Measured: baseline
Association Between Lifestyle Factors and Hepatic Steatosis
Association between Mediterranean diet adherence (assessed by MEDAS score) and physical activity level (assessed by IPAQ) with hepatic steatosis assessed by CAP (dB/m)
Measured: Baseline
Association of Circulating Biomarkers With MASLD
Association of serum biomarkers (uric acid, ferritin, vitamin D) with MASLD presence defined by CAP ≥248 dB/m
Measured: baseline
Secondary outcomes (1)
Prevalence of Significant Fibrosis
Proportion of participants with significant liver fibrosis defined by liver stiffness measurement (LSM ≥8 kPa) assessed by vibration-controlled transient elastography
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 Jan 2023
- Primary completion31 May 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)Studies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548970
- Sponsor's protocol ID
- UMIUC-26-5
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Characterization of Metabolic Dysfunction-Associated Steatotic Liver Disease Among Risk Groups in Turkey
- ClinicalTrials.gov ID
- NCT07548970
- Acronym / sponsor ID
- UMIUC-26-5
- Conditions
- MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), Mediterranean Diet, Lifestyle (Sedentary Behavior and Physical Activity), Vitamin D Deficiency, Hyperuricemia and MAFLD, Ferritin
- Keywords
- MASLD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 23 Apr 2026 (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.
MASLD is with 25% the most prevalent liver disorder in Western society and is associated with overweight, obesity, metabolic syndrome (MetS), type 2 diabetes mellitus (T2DM) and cardiovascular diseases (CVD). MASLD is defined by a hepatic fat accumulation of more than 5% in the absence of classical causes of steatogenesis (e.g. alcohol and steatogenic drugs). It represents a broad spectrum of clinical entities from steatosis to advanced liver disease with hepatic failure. Most of the patients have simple steatosis, however in about 15-30% steatohepatitis (MASH) develops, which leads to an overall increase in morbidity and mortality due to the progression to fibrosis, cirrhosis and hepatocellular carcinoma (HCC). Patients with MASLD have no or few, mainly specific symptoms; and generally there is a silent progression of simple steatosis to NASH and in the end liver-related morbidity and mortality. Despite the clinical importance and the potential impact on healthcare resources, the majority of MASLD patients are currently not detected due to the lack of non-invasive methods to diagnose MASLD. To date, the prevalance of MASLD in Turkey among subjects at risk, and its relation to common comorbidities such as obesity, T2DM and CVD is not clear. Therefore, identification of MASLD patients in this cohort will give information on the prevalence in the group of uncomplicated overweight and obesity and those with concomitant cardiometabolic diseases. By early detecting these patients at risk to develop progressive liver diseases and extrahepatic manifestations, it will be possible to intervene and improve health. Within this context, this study aims to detect prevalence of MASLD among risk groups. Also, the risk factors related to MASLD etiology and progression, such as overweight, obesity, T2DM, CVD, diet and physical activity will be studied to have a better understanding of their presumed causal relationship with MASLD.
This study is designed to study the prevalence of and risk factors associated with MASLD in adult populations at-risk of MASLD. Participants will undergo liver assessments via vibration controlled transient elastography. Lifestyle, demographic, and biochemical data will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 459 male and female participants aged between 18-80, who can sign the informed consent and are eligible to participate.
Key inclusion criteria (6 listed)
- BMI ≥ 25 kg/m2 OR WC> 94 cm (M) 80 cm (F)
- Fasting serum glucose ≥ 100 mg/dL OR 2-hour post-load glucose levels ≥140 mg/dL OR HbA1c ≥ 5.7% OR type 2 diabetes OR treatment for type 2 diabetes
- Blood pressure ≥ 130/85 mmHg OR specific antihypertensive drug treatment
- Plasma triglycerides ≥ 150 mg/dL OR lipid lowering treatment
- Plasma HDL-cholesterol ≤40 mg/dL (Male) and ≤ 50 mg/dL (Female) OR lipid lowering treatment
Key exclusion criteria (16 listed)
- Excessive alcohol use (more than 20 g/day for women and 30g/day for men= >2 glasses alcohol/day for women and >3 glasses for men)
- Hepatitis B virus,
- Hepatitis C virus,
- Autoimmune hepatitis,
- Primary biliary cirrhosis,
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 Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Time frame: baseline
Proportion of participants with hepatic steatosis defined by controlled attenuation parameter (CAP ≥248 dB/m) measured using vibration-controlled transient elastography
Association Between Lifestyle Factors and Hepatic Steatosis
Time frame: Baseline
Association between Mediterranean diet adherence (assessed by MEDAS score) and physical activity level (assessed by IPAQ) with hepatic steatosis assessed by CAP (dB/m)
Association of Circulating Biomarkers With MASLD
Time frame: baseline
Association of serum biomarkers (uric acid, ferritin, vitamin D) with MASLD presence defined by CAP ≥248 dB/m
1 secondary outcome
Prevalence of Significant Fibrosis
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease) and Mediterranean Diet, run by Maastricht University Medical Center at 1 site in Turkey (Türkiye).
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 6 inclusion and 16 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: finished, as of the sponsor's last update on 23 Apr 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2026.