Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
the change in visceral adipose tissue |
the change in visceral adipose tissue (pretreatment-post-treatment) after achievement of the weight loss target |
until achievement of the weight loss target,an average of 12 weeks |
|
| Secondary |
menstrual frequency |
number of menstruation in a year |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
systolic blood pressure |
systolic blood pressure (SBP), mmHg |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
diastolic blood pressure |
diastolic blood pressure (DBP), mmHg |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
fasting plasma glucose |
fasting plasma glucose (FPG), mmol/L |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
postprandial plasma glucose |
postprandial plasma glucose (PPG), mmol/L |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
fasting insulin |
fasting insulin (FINS), mU/L |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
postprandial insulin |
postprandial insulin (PINS), mU/L |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
glycosylated hemoglobin A1c |
glycosylated hemoglobin A1c (HbA1c), % |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
homeostasis model assessment of insulin resistance |
homeostasis model assessment of insulin resistance (HOMA-IR) |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
alanine aminotransferase |
alanine aminotransferase (ALT), U/L |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
aspartate aminotransferase |
aspartate aminotransferase (AST), U/L |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
Total cholesterol |
Total cholesterol (TC), mmol/L |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
Triglycerides |
Triglycerides (TG), mmol/L |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
high-density lipoprotein cholesterol |
high-density lipoprotein cholesterol (HDL-c), mmol/L |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
low-density lipoprotein cholesterol |
low-density lipoprotein cholesterol (LDL-c), mmol/L |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
Creatinine |
Creatinine (Cr), umol/L |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
serum uric acid |
serum uric acid (SUA), umol/L |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
luteinizing hormone |
luteinizing hormone (LH), IU/L |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
follicle-stimulating hormone |
follicle-stimulating hormone (FSH), IU/L |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
pituitary prolactin |
pituitary prolactin (PRL), mIU/L |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
total testosterone |
total testosterone (TT), ng/ml |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
free testosterone |
free testosterone (FT), pg/ml |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
Sex hormone binding globulin |
Sex hormone binding globulin (SHBG), nmol/L |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
Androstenedione |
Androstenedione (AD), ng/ml |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
dehydroepiandrosterone sulfate |
dehydroepiandrosterone sulfate (DHEAS), ug/dl |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
controlled attenuation parameter |
controlled attenuation parameter (CAP), dB/m |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
liver stiffness measurement |
liver stiffness measurement (LSM), kPa |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
total body fat |
percentage of total body fat, % |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
total body lean |
percentage of total body lean, % |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
total fat mass |
total fat mass, kg |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
total lean mass |
total lean mass, kg |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
| Secondary |
the change in subcutaneous adipose tissue |
the change in subcutaneous adipose tissue (pretreatment-post-treatment) after achievement of the weight loss target |
from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
|
