Quantitative US for Evaluation of Hepatic Steatosis in MAFLD With UDFF
ConditionFatty Liver Disease, Nonalcoholic
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorQianfoshan Hospital
About this trial
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 Disease (NAFLD), is the most common chronic liver disease in the world at present, with a incidence rate of about 30%. In the United States, NAFLD is the third leading cause of hepatocellular carcinoma, and early assessment and diagnosis of liver steatosis characteristics are crucial for timely treatment or intervention to reduce the risk of liver fibrosis and inhibit disease progression. Liver biopsy is considered as the "gold standard" for evaluating, grading, and determining inflammatory activity of liver steatosis and fibrosis. However, liver biopsy are invasive and pathological evaluation differences among observers, which makes it difficult to widely use and repeat, especially for dynamic evaluation of patients during the treatment process.
Ultrasound Derviced Fat Fraction (UDFF) is a unique technology for non-invasive quantification of liver fat content, which is equipped on the Siemens ACUSON Sequoia ultrasound system. UDFF is calculated from two parameter values: attenuation coefficient (AC) and backscatter coefficient (BSC). SWE (shear wave elastography) is becoming widely used, and is recommended for the evaluation of liver fibrosis by some guidelines in patients with chronic liver diseases, such as viral hepatitis. These two technologies (UDFF+SWE) can be achieved on the same probe, and this detection technology is non-invasive, painless, simple, and reliable.
Bariatric surgery (BS), also known as metabolic weight loss surgery, is currently recognized as the most significant and long-lasting method for treating obesity. It can significantly improve obesity related comorbidities, as well as long-term improvement in postoperative quality of life and mental state.
This study will aim on analysis of the liver ultrasound characteristics of patients who plan to undergo bariatric surgery. By using UDFF and elastic shear wave technology (UDFF+SWE), a new non-invasive ultrasound evaluation method for MAFLD grading diagnosis of simple fatty liver, fatty hepatitis, liver fibrosis, and related cirrhosis will be proposed, and the incidence and risk factors of MAFLD in overweight and obese patients will be explored, The reversal effect of weight loss therapy on MAFLD in obese patients.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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.
Trial design
Treatments tested in this trial
- bariatric surgery (BS)
Treatment groups
200 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov