💬In plain words
What the trial is, and whether it could suit you
This study will look at the health characteristics of adults with metabolic dysfunction-associated steatotic liver disease (MASLD) in Kazakhstan. Researchers want to better understand how this liver condition appears in people in Kazakhstan and how it is managed in everyday medical care.
About 420 adults with MASLD will take part. Researchers will collect information from their medical records, laboratory tests, liver imaging, and questionnaires.
A smaller group of about 65 participants in Almaty who were already prescribed Ursosan® by their doctor before joining the study will be followed for 6 months. Researchers will look at changes in a liver enzyme called alanine aminotransferase (ALT) and other measures of liver health. The study does not assign Ursosan® or any other treatment. Treatment decisions are made by each participant's doctor as part of their usual medical care.
The res
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:1. Men and women aged 18 to 65 years. 2. Voluntary willingness to provide informed consent to participate in the study.
3\. Imaging-confirmed hepatic steatosis based on ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI).
4\. At least one confirmed criterion of metabolic dysfunction-associated steatotic liver disease (MASLD), according to the EASL 2024 diagnostic criteria, including:
* Obesity or overweight:
* Body mass index ≥25 kg/m² (≥23 kg/m² in people of Asian ethnicity);
* Waist circumference ≥94 cm in men and ≥80 cm in women of European ethnicity, or ≥90 cm in men and ≥80 cm in women of Asian ethnicity;
* Hyperglycemia or type 2 diabetes mellitus:
* Prediabetes: HbA1c 39-47 mmol/mol (5.7-6.4%), or fasting plasma glucose 5.6-6.9 mmol/L (100-125 mg/dL), or 2-hour plasma glucose during an oral glucose tolerance test 7.8-11.0 mmol/L (140-199 mg/dL); or
* Type 2 diabetes mellitus: HbA1c ≥48 mmol/mol (≥6.5%), or fasting plasma glucose ≥7.0 mmol/L (≥126 mg/dL), or 2-hour plasma glucose during an oral glucose tolerance test ≥11.1 mmol/L (≥200 mg/dL), or treatment for type 2 diabetes mellitus;
* Plasma triglycerides ≥1.7 mmol/L (≥150 mg/dL) or lipid-lowering treatment;
* HDL cholesterol ≤1.0 mmol/L (≤39 mg/dL) in men and ≤1.3 mmol/L (≤50 mg/dL) in women, or lipid-lowering treatment;
* Blood pressure ≥130/85 mmHg or treatment for hypertension.
Additional Inclusion Criteria for the Prospective Cohort Subgroup:
1. Participants undergoing evaluation in Almaty.
2. ALT level ≥1.5 times the upper limit of normal, with the upper limit of normal defined as 29-33 U/L for men and 19-25 U/L for women.
3. Participants receiving Ursosan® therapy prescribed by a physician as part of routine clinical practice no more than 4 weeks before study enrollment, independently of participation in this study.
Exclusion Criteria: 1. Drug-induced liver injury, including long-term treatment with glucocorticosteroids, tamoxifen, amiodarone, irinotecan, methotrexate, lomitapide, valproate, or 5-fluorouracil.
2\. Wilson disease, hypobetalipoproteinemia, lysosomal acid lipase deficiency, celiac disease, hemochromatosis, or cryptogenic hepatic steatosis, based on medical history.
3\. Autoimmune liver diseases, including primary biliary cholangitis (PBC), autoimmune hepatitis (AIH), primary sclerosing cholangitis (PSC), etc., based on medical history.
4\. Lipodystrophy, based on medical history. 5. Endocrine disorders, including growth hormone deficiency and primary or secondary panhypopituitarism, based on medical history.
6\. Nutritional deficiency or malnutrition. 7. Parenteral nutrition. 8. Bariatric surgery. 9. Anorexia. 10. Pregnancy. 11. Polycystic ovary syndrome. 12. Type 1 diabetes mellitus. 13. Hypothyroidism. 14. Chronic dialysis. 15. Active malignancy at the time of study enrollment. 16. Signs of psychiatric disorders. 17. Inability to comply with the study protocol or any other reason that, in the investigator's opinion, may prevent successful participation in the study.
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