Status:
NOT_YET_RECRUITING
Quantitative US for Evaluation of Hepatic Steatosis in MAFLD With UDFF
Lead Sponsor:
Qianfoshan Hospital
Conditions:
Fatty Liver Disease, Nonalcoholic
Eligibility:
All Genders
18-85 years
Brief Summary
Ultrasound Derived Fat Fraction (UDFF) Evaluation of Metabolic Related Fatty Liver Disease (MAFLD) in obesity Patients Metabolic fatty liver disease (MAFLD), formerly known as Nonalcoholic Fatty Liver...
Detailed Description
1\. Research background MAFLD (NAFLD) is considered to be the most common adult chronic liver disease in the world, affecting more than 30% of the world's population. Previous studies have shown that...
Eligibility Criteria
Inclusion
- Chinese citizens aged 18 ≤ 85;
- Routine ultrasound reveals diffuse or non-uniform fatty liver disease in the liver;
- Conform to the MAFLD diagnostic criteria issued by the international guidelines: histological (liver biopsy), imaging or blood biomarker evidence based on liver fat accumulation (hepatocyte steatosis), and combine one of the following three conditions: overweight/obesity (BMI ≥ 23 kg/m2), type 2 diabetes, and metabolic dysfunction. The definition of metabolic dysfunction is the presence of at least two of the following metabolic risk factors: 1. waist circumference (for Asians) ≥ 90/80 cm (male/female);2. Arterial blood pressure ≥ 130/85 mmHg is being treated with antihypertensive drugs; 3. Hypertriglyceridemia (TG): fasting serum TG ≥ 150 mg/dl (≥ 1.70 mmol/L) or being treated with lipid-lowering drugs; 4. High density lipoprotein cholesterol (HDL-c) emia: fasting serum HDL-c\<40 mg/dl (\<1.0 mmol/L) for males,\<50 mg/dl (\<1.3 mmol/L) for females, or specific medication treatment;5. Pre diabetes (i.e. fasting blood glucose level 100-125 mg/dl \[5.6-6.9 mmol/L\], or blood glucose level 140-199 mg/dl \[7.8-11.0 mmol\] 2 hours after meal or HbA1c 5.7% -6.4% \[39-47 mmol/mol\]);6. Steady state model evaluation of insulin resistance score ≥ 2.5;7. Plasma C-reactive protein levels\>2 mg/L.
- Those who plan to undergo liver histopathological diagnosis or MRI-PDFF assessment of the degree of fatty liver within one week;
- No significant risk of bleeding (platelet ≥ 50x109/L, international standardized ratio of prothrombin time INR ≤ 1.5);
- The patient agrees to join this study and signs an informed consent form.
Exclusion
- 1\. No histopathological diagnosis or MRI-PDFF was found;
- 2\. The interval between the ultrasound UDFF examination and the histopathological examination or MRI-PDFF examination is more than one week;
- 3\. Pregnancy;
- 4\. Incomplete medical history information.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06097338
Start Date
October 1 2023
End Date
September 1 2026
Last Update
October 24 2023
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