Identification and Characterization of At-risk MASLD in Turkish Adults

NCT07548970 | Completed

• 1 other identifier: UMIUC-26-5
• Study Type: observational
• Target: 459
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (3)

• 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

  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)

  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

  baseline

Secondary Outcomes (1)

• Prevalence of Significant Fibrosis

  baseline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Istanbul University - Cerrahpasa: collaborator

Study Sites (1)

Temel Tıp Bilimleri

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity; Vitamin D Deficiency; Hyperuricemia

Condition Hierarchy (Ancestors)

Behavior; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 23, 2026
• Study Start: January 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

TU (1)