ClinicalTrials.gg
CompletedNCT07548970Updated Apr 23, 2026

Identification and Characterization of At-risk MASLD in Turkish Adults

An observational study in MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), Mediterranean Diet and Lifestyle (Sedentary Behavior and Physical Activity), sponsored by Maastricht University Medical Center. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Maastricht University Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
459
Ages
18 Years to 80 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
  • Mediterranean Diet
  • Lifestyle (Sedentary Behavior and Physical Activity)
  • Vitamin D Deficiency
  • Hyperuricemia and MAFLD
  • Ferritin

Keywords

  • MASLD
03

In context

Sedentary Behavior

1,273 studies on the registry are indexed under Sedentary Behavior; 300 are open to participants now.

This study's enrollment of 459 is above the median of 158 across 176 observational studies indexed under Sedentary Behavior.

Browse Sedentary Behavior studies →

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 853 studies on the registry; 114 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

459 male and female participants aged between 18-80, who can sign the informed consent and are eligible to participate.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

One of the following conditions:

  • ≥ 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 ≥ 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

Exclusion criteria

Exclusion Criteria:

  • 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)
  • virus,
  • virus,
  • hepatitis,
  • Primary biliary cirrhosis,
  • Hemochromatosis,
  • Wilson's disease,
  • Alpha 1 antitrypsin deficiency
  • HCV Genotype 3,
  • Total parental nutrition,
  • Current use of hepatotoxic medications (amiodarone, tamoxifen, methotrexate, 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 (s) or prior diagnosis within last 5 years.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
459 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline

  2. 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)

    Time frame: Baseline

  3. Association of Circulating Biomarkers With MASLD

    Association of serum biomarkers (uric acid, ferritin, vitamin D) with MASLD presence defined by CAP ≥248 dB/m

    Time frame: 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

    Time frame: baseline

07

Study locations

1 site
  • Temel Tıp Bilimleri
    Istanbul, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2023 to primary completion in May 2024, 16 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 14, 2026
First posted
Apr 23, 2026
StartActual
Jan 1, 2023
Primary completionActual
May 31, 2024
CompletionActual
Dec 31, 2024
Last update
Apr 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07548970
Responsible party
Sponsor
First posted
Apr 23, 2026
Start date
Jan 1, 2023
Primary completion
May 31, 2024
Completion
Dec 31, 2024
Last update
Apr 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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