Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Body weight changes |
Body weight changes measured in kilogram |
Change from Baseline Body Weight at week 12 |
|
Primary |
Body weight changes |
Body weight changes measured in kilogram |
Change from Baseline Body Weight at week 24 |
|
Primary |
Body mass index (BMI) changes |
Body mass index changes measured in kg/m^2 (weight in kilograms, height in meters) |
Change from Baseline BMI at week 12 |
|
Primary |
Body mass index (BMI) changes |
Body mass index changes measured in kg/m^2 (weight in kilograms, height in meters) |
Change from Baseline BMI at week 24 |
|
Primary |
Waist-Hip Ratio (WHR) changes |
WHR changes measured in centimeters (waist and hip circumference in centimeters) |
Change from Baseline WHR at week 12 |
|
Primary |
Waist-Hip Ratio (WHR) changes |
WHR changes measured in centimeters (waist and hip circumference in centimeters) |
Change from Baseline WHR at week 24 |
|
Primary |
Body Fat Percentage changes |
Body Fat Percentage changes measured in percentage |
Change from Baseline Body Fat Percentage at week 12 |
|
Primary |
Body Fat Percentage changes |
Body Fat Percentage changes measured in percentage |
Change from Baseline Body Fat Percentage at week 24 |
|
Primary |
Body Fat Mass changes |
Body Fat Mass changes measured in kilograms |
Change from Baseline Body Fat Mass at week 12 |
|
Primary |
Body Fat Mass changes |
Body Fat Mass changes measured in kilograms |
Change from Baseline Body Fat Mass at week 24 |
|
Primary |
Fat Free Mass changes |
Fat Free Mass changes measured in kilograms |
Change from Baseline Body Fat Mass at week 12 |
|
Primary |
Fat Free Mass changes |
Fat Free Mass changes measured in kilograms |
Change from Baseline Body Fat Mass at week 24 |
|
Primary |
Systolic Blood Pressure changes |
Systolic Blood Pressure changes measured in mmHg |
Change from Baseline Systolic Blood Pressure at week 12 |
|
Primary |
Systolic Blood Pressure changes |
Systolic Blood Pressure changes measured in mmHg |
Change from Baseline Systolic Blood Pressure at week 24 |
|
Primary |
Diastolic Blood Pressure changes |
Diastolic Blood Pressure changes measured in mmHg |
Change from Baseline Diastolic Blood Pressure at week 12 |
|
Primary |
Diastolic Blood Pressure changes |
Diastolic Blood Pressure changes measured in mmHg |
Change from Baseline Diastolic Blood Pressure at week 24 |
|
Primary |
Fasting Blood Glucose changes |
Fasting Blood Glucose changes measured in mmol/L |
Change from Baseline Fasting Blood Glucose at week 12 |
|
Primary |
Fasting Blood Glucose changes |
Fasting Blood Glucose changes measured in mmol/L |
Change from Baseline Fasting Blood Glucose at week 24 |
|
Primary |
2-hour Post Prandial Blood Glucose changes |
2-hour Post Prandial changes measured in mmol/L |
Change from Baseline 2-hour Post Prandial at week 12 |
|
Primary |
2-hour Post Prandial Blood Glucose changes |
2-hour Post Prandial changes measured in mmol/L |
Change from Baseline 2-hour Post Prandial at week 24 |
|
Primary |
HbA1c changes |
HbA1c changes measured in percentage |
Change from Baseline HbA1c at week 12 |
|
Primary |
HbA1c changes |
HbA1c changes measured in percentage |
Change from Baseline HbA1c at week 24 |
|
Primary |
Fasting Total Cholesterol changes |
Fasting Total Cholesterol changes measured in mmol/L |
Change from Baseline Fasting Total Cholesterol at week 12 |
|
Primary |
Fasting Total Cholesterol changes |
Fasting Total Cholesterol changes measured in mmol/L |
Change from Baseline Fasting Total Cholesterol at week 24 |
|
Primary |
Fasting Triglyceride changes |
Fasting Triglyceride changes measured in mmol/L |
Change from Baseline Fasting Triglyceride at week 12 |
|
Primary |
Fasting Triglyceride changes |
Fasting Triglyceride changes measured in mmol/L |
Change from Baseline Fasting Triglyceride at week 24 |
|
Primary |
Fasting High-density Lipoprotein-Cholesterol (HDL-C) changes |
Fasting HDL-C measured in mmol/L |
Change from Baseline Fasting HDL-C at week 12 |
|
Primary |
Fasting High-density Lipoprotein-Cholesterol (HDL-C) changes |
Fasting HDL-C measured in mmol/L |
Change from Baseline Fasting HDL-C at week 24 |
|
Primary |
Fasting Low-density Lipoprotein-Cholesterol (LDL-C) changes |
Fasting LDL-C measured in mmol/L |
Change from Baseline Fasting LDL-C at week 12 |
|
Primary |
Fasting Low-density Lipoprotein-Cholesterol (LDL-C) changes |
Fasting LDL-C measured in mmol/L |
Change from Baseline Fasting LDL-C at week 24 |
|
Primary |
Fasting Insulin changes |
Fasting Insulin measured in uU/ml |
Change from Baseline Fasting Insulin at week 12 |
|
Primary |
Fasting Insulin changes |
Fasting Insulin measured in uU/ml |
Change from Baseline Fasting Insulin at week 24 |
|
Secondary |
Quality of Life changes |
Quality of Life score measured by Obesity and Weight-Loss Quality of Life (OWLQOL ) questionnaire |
At baseline, week 12 and week 24 |
|
Secondary |
Dietary Intake changes |
Dietary intake changes measured by Food Frequency Questionnaire (FFQ) |
At baseline, week 12 and week 24 |
|