Assessing the change in BMI(kilogram/square meter, kg/m²) classification compared to baseline(Based on the BMI classification in Chinese adiposity diagnosis and treatment guideline 2024)
Time frame · At 48th week post procedure
BMI classification in China: BMI 18.5-24 kg/m² healthy; 24\<BMI\<28 kg/m² overweight, 28\<BMI\<32.5 kg/m² mild obesity, 32.5\<BMI\<37.5 kg/m² moderately obese, BMI\>37.5 kg/m² severe or extremely severe obesity
Assessing the rate of total body weight loss(TBWL%) compared to baseline
Time frame · At 48th week post procedure
Total body weight loss (TBWL) is the pre-op weight minus the post op body weight
Assessing the change of waist circumference(centimeter, cm) compared to baseline
Time frame · at 48th week post procedure
waist circumference is measured with centimeter(cm)
Assessing the change of hip circumference(centimeter, cm) compared to baseline
Time frame · At 48th week post procedure
Hip circumference is measured with centimeter(cm).
Assessing the change of blood pressure(incl. systolic blood pressure and diastolic blood pressure) compared to baseline(Hydrargyrum, mmHg)
Time frame · At 48th week post procedure
Blood pressure is measured with mmHg.
Assessing the percentage change(%) of body fat or fat-free mass compared to baseline
Time frame · At 48th week post procedure
Body fat or fat-free mass is measured by dual energy X-ray absorptiometry(DEXA)
Assessing the percentage change(%) of liver fat content or pancreatic fat content compared to baseline
Time frame · At 48th week post procedure
Liver fat content or pancreatic fat content is measured with Magnetic resonance imaging-derived proton density fat fraction(MRI-PDFF)
Assessing the percentage change(%) of triglyceride(TG), low-density lipoprotein cholesterol(LDL-C),total cholesterol(TC) or high-density lipoprotein cholesterol(HDL-C) compared to baseline
Time frame · At 48th week post procedure
TG(millimoles per liter, mmol/L) , LDL-C(millimoles per liter, mmol/L) ,TC(millimoles per liter, mmol/L) or HDL-C(millimoles per liter, mmol/L) is tested in the lab of study sites with local standards according to Chinese Guidelines for Lipid Management
Assessing the change of aspartate transaminase(AST) or alanine aminotransferase(ALT) compared to baseline
Time frame · At 48th week post procedure
Assessing the change(%) of serum uric acid compared to baseline
Time frame · At 48th week post procedure
serum uric acid(micromoles per liter, µmol/L) is tested in the lab of study sites according to Chinese National Standards