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NCT07548970Completed

Identification and Characterization of At-risk MASLD in Turkish Adults

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

Source: ClinicalTrials.gov · Last updated 23 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
459 (actual)
First submitted
14 Apr 2026
Start date
1 Jan 2023
Primary completion date
31 May 2024
Lead sponsor
Maastricht University Medical Center
NCT number
NCT07548970

What you commit to

  • Study type: Observational
  • Participants enrolled: 459
  • From 1 Jan 2023 to the primary completion date, 31 May 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current use of hepatotoxic medications (amiodarone, tamoxifen, methotrexate, corticosteroids and HAART),
  • Current diagnosis of extrahepatic malignancy(s) or prior diagnosis within last 5 years.

Other illness

  • Hepatitis B virus,
  • Hepatitis C virus,
  • Autoimmune hepatitis,
  • Wilson's disease,
  • HCV Genotype 3,
  • Celiac disease,
  • A history of bariatric surgery

Other

  • 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)
  • Primary biliary cirrhosis,
  • Hemochromatosis,
  • Alpha 1 antitrypsin deficiency
  • Total parental nutrition,
  • Pregnancy and breastfeeding
  • Current diagnosis of liver cirrhosis and/or hepatocellular carcinoma.

Who the study is looking for

  • 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

Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Temel Tıp Bilimleri
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.