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NCT Number: NCT07548970

Identification and Characterization of At-risk MASLD in Turkish Adults

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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)
  • Hepatitis B virus,
  • Hepatitis C virus,
  • Autoimmune 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, 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.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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)

  3. 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

Secondary outcomes

  1. Prevalence of Significant Fibrosis

    Time frame: baseline

    Proportion of participants with significant liver fibrosis defined by liver stiffness measurement (LSM ≥8 kPa) assessed by vibration-controlled transient elastography

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Istanbul University - Cerrahpasa

Registry information

Official study title

Identification and Characterization of Metabolic Dysfunction-Associated Steatotic Liver Disease Among Risk Groups in Turkey

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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