Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Incretine response to different nutritive stimulations |
Concentration of GLP-1 after different test meals will be analysed by ELISA before and after weight loss |
3 month |
|
Primary |
Incretine response to different nutritive stimulations |
Concentration of GIP after different test meals will be analysed by ELISA before and after weight loss |
3 month |
|
Primary |
Incretine response to different nutritive stimulations |
Concentration of Ghrelin after different test meals will be analysed by ELISA before and after weight loss |
3 month |
|
Secondary |
Correlation of the GLP-1 responses with the reduction of hunger (questionnaire) after a nutritive stimulation by different nutritional components |
GLP-1 (concentration) will be measured by ELISA, hunger feeling will be measured by questionnaire using a visual analog score (from 1 (less) to 10 (more)) |
3 month |
|
Secondary |
correlation of the GIP responses with the reduction of hunger (questionnaire)after a nutritive stimulation by different nutritional components |
GIP (concentration) will be measured by ELISA, hunger feeling will be measured by questionnaire using a visual analog score (from 1 (less) to 10 (more)) |
3 month |
|
Secondary |
Correlation of the Ghrelin responses with the reduction of hunger (questionnaire) after a nutritive stimulation by different nutritional components |
Ghrelin (concentration) will be measured by ELISA, hunger feeling will be measured by questionnaire using a visual analog score (from 1 (less) to 10 (more)) |
3 month |
|
Secondary |
Correlation of the insulin responses with the reduction of hunger (questionnaire) after a nutritive stimulation by different nutritional components |
insulin (concentration) will be measured by ELISA, hunger feeling will be measured by questionnaire using a visual analog score (from 1 (less) to 10 (more)) |
3 month |
|
Secondary |
-differences of substrate utilization depending on the nutritional composition |
postprandial thermogenesis will be assessed by indirect caloriemetry |
3 month |
|
Secondary |
-differences of substrate utilization depending on the nutritional composition |
postprandial glucose concentration (physiological parameter) will be assessed in skeletal muscle and adipose tissue by microdialysis |
3 month |
|
Secondary |
-differences of substrate utilization depending on the nutritional composition |
postprandial pyruvate concentration (physiological parameter) will be assessed in skeletal muscle and adipose tissue by microdialysis |
3 month |
|
Secondary |
-differences of substrate utilization depending on the nutritional composition |
postprandial lactate concentration (physiological parameter) will be assessed in skeletal muscle and adipose tissue by microdialysis |
3 month |
|
Secondary |
-differences of lipolysis depending on the nutritional composition |
postprandial glycerol concentration (physiological parameter) will be assessed by microdialysis |
3 month |
|
Secondary |
-Change of hepatic insulin sensitivity after weight loss |
hepatic insulin sensitivity assessed via endogenous glucose production measured in mg/kg/min |
3 month |
|
Secondary |
-Change of meal induced GLP-1 concentration during weight loss |
Concentration of GLP-1 after different test meals will be analysed by ELISA |
3 month |
|
Secondary |
-Change of meal induced GIP concentration during weight loss |
Concentration of GIP after different test meals will be analysed by ELISA |
3 month |
|
Secondary |
-Change of meal induced Ghrelin concentration during weight loss |
Concentration of Ghrelin after different test meals will be analysed by ELISA |
3 month |
|
Secondary |
-Weight loss mediated changes of meal induced GLP-1 concentration in insulin resistant vs insulin sensitive subjects |
Insulin sensitivity assessed via insulin sensitivity index |
3 month |
|
Secondary |
-Weight loss mediated changes of meal induced GIP concentration in insulin resistant vs insulin sensitive subjects |
Insulin sensitivity assessed via insulin sensitivity index |
3 month |
|
Secondary |
-Weight loss mediated changes of meal induced Ghrelin concentration in insulin resistant vs insulin sensitive subjects |
Insulin sensitivity assessed via insulin sensitivity index |
3 month |
|
Secondary |
Change of fat distribution after weight loss |
total fat mass will be assessed |
3 month |
|
Secondary |
Change of fat distribution after weight loss |
visceral fat mass will be assessed |
3 month |
|
Secondary |
Change of fat distribution after weight loss |
hepatic fat mass will be assessed |
3 month |
|
Secondary |
Change of skeletal muscle mass after weight loss |
skeletal muscle mass will be assessed |
3 month |
|
Secondary |
Prediction of weight regain (weight in kilograms and height in meters will be combined to report BMI in kg/m^2). |
Analysis of the predictive impact of hormones like GLP-1, Ghrelin, GIP and insulin in the context of body weight regain. Linear and logistic regression models will be used to identify predictive biomarkers |
12 months |
|
Secondary |
Prediction of weight regain (weight in kilograms and height in meters will be combined to report BMI in kg/m^2). |
Analysis of the predictive impact of hormones like GLP-1, Ghrelin, GIP and insulin in the context of insulin sensitivity. Linear and logistic regression models will be used to identify predictive biomarkers |
12 months |
|
Secondary |
Prediction of weight regain (weight in kilograms and height in meters will be combined to report BMI in kg/m^2). |
Analysis of the predictive impact of hormones like GLP-1, Ghrelin, GIP and insulin in the context of insulin sensitivity. Linear and logistic regression models will be used to identify predictive biomarkers |
24 months |
|
Secondary |
Prediction of weight regain (weight in kilograms and height in meters will be combined to report BMI in kg/m^2). |
Analysis of the predictive impact of hormones like GLP-1, Ghrelin, GIP and insulin in the context of body weight regain. Linear and logistic regression models will be used to identify predictive biomarkers |
24 months |
|
Secondary |
To analyse the long term course of body weight after 12 month |
Measurement of body weight after 12 months |
12 months |
|
Secondary |
To analyse the long term course of body weight after 24 month |
Measurement of body weight after 24 months |
24 months |
|
Secondary |
To analyse the long term course of body weight after 36 month |
Measurement of body weight after 36 months |
36 months |
|
Secondary |
To analyse the long term course of body weight after 48 month |
Measurement of body weight after 48 months |
48 months |
|