The investigators here propose to perform a collaborative clinical research effort including a randomized controlled trial investigating the mechanisms of weight maintenance and their relation to a lifestyle intervention in children, adolescents and adults. The detailed investigation and analysis of the variability and dynamics of the endocrine circuits responding to a negative energy balance and weight loss will be accompanied and enhanced by specific clinical projects targeting peripheral and central-nervous aspects of hormonal counter-regulation after weight loss. Mechanisms of endocrine counter-regulation and potential therapeutic approaches will be studied.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
286
After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults
no intervention, only follow up
Charite
Berlin, Germany
BMI will be assessed during lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo
BMI (kg/m2) will be analyzed after intentional weight loss in two comparable parts of a randomized controlled trial including (1) children and adolescents and (2) adults. Therefore effects of a multimodal lifestyle intervention will be compared to placebo.
Time frame: 21 months
Evaluation of leptin during lifestyle intervention
Measurement of leptin at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
Time frame: month -3, month 0, month 12, month 18
Evaluation of leptin during follow up
Measurement of leptin during follow up until the 48 months
Time frame: 48 months
Evaluation of catecholamines during follow up
Measurement of catecholamines during follow up until the 48 months
Time frame: 48 months
Evaluation of catecholamines during lifestyle intervention
Measurement of catecholamines at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
Time frame: month -3, month 0, month 12, month 18
Evaluation of cortisol during lifestyle intervention
Measurement of cortisol at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
Time frame: month -3, month 0, month 12, month 18
Evaluation of cortisol during follow up
Measurement of cortisol during follow up until the 48 months
Time frame: 48 months
Evaluation of glucagon-like peptide 1 (GLP1) during lifestyle intervention
Measurement of GLP1 at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
Time frame: month -3, month 0, month 12, month 18
Evaluation of GLP1 during follow up
Measurement of GLP1 during follow up until the 48 months
Time frame: 48 months
Evaluation of glucose-dependent insulinotropic polypeptide (GIP) during lifestyle intervention
Measurement of GIP at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
Time frame: month -3, month 0, month 12, month 18
Evaluation of GIP during follow up
Measurement of GIP during follow up until the 48 months
Time frame: 48 months
Evaluation of thyroid hormones during lifestyle intervention
Measurement of thyroid hormones at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
Time frame: month -3, month 0, month 12, month 18
Evaluation of thyroid hormones during follow up
Measurement of thyroid hormones during follow up until the 48 months
Time frame: 48 months
Evaluation of insulin during lifestyle intervention
Measurement of insulin at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
Time frame: month -3, month 0, month 12, month 18
Evaluation of insulin during follow up
Measurement of insulin during follow up until the 48 months
Time frame: 48 months
Evaluation of insulin-like growth factor 1 (IGF1) during lifestyle intervention
Measurement of IGF1 at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
Time frame: month -3, month 0, month 12, month 18
Evaluation of IGF1 during follow up
Measurement of IGF1 during follow up until the 48 months
Time frame: 48 months
Evaluation of natriuretic peptide during lifestyle intervention
Measurement of natriuretic peptide at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
Time frame: month -3, month 0, month 12, month 18
Evaluation of natriuretic peptide during follow up
Measurement of natriuretic peptide during follow up until the 48 months
Time frame: 48 months
Evaluation of blood pressure during lifestyle intervention
Measurement of blood pressure at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
Time frame: month -3, month 0, month 12, month 18, month 24, month 36, month 48
Evaluation of free fatty acids (FFAs) during lifestyle intervention
Measurement of FFAs at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
Time frame: month -3, month 0, month 12, month 18, month 24, month 36, month 48
Evaluation of respiratory coefficient during lifestyle intervention
Measurement of respiratory coefficient at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
Time frame: month -3, month 0, month 12, month 18, month 24, month 36, month 48
Measurement of messenger ribonucleic acid (mRNA) changes in adipose and skeletal muscle before (T-3), after weight loss (T0) and after as well as after 12 months randomized lifestyle intervention (or placebo)
Measurement of systemic and tissue specific changes in adipose tissue and skeletal muscle using RNA sequencing (counts)
Time frame: month -3, month 0, month 12
Measurement of insulin sensitivity
Measurement of systemic and tissue specific changes in adipose and muscle insulin sensitivity using hyperinsulinemic clamp (mg•kg-1•min-1/(mU•L-1)) before (T-3), after weight loss (T0) and after as well as after 12 months randomized lifestyle intervention (or placebo)
Time frame: month -3, month 0, month 12
Prediction of body weight regain
No additional measurement will be done. However, we will analyse the predictive impact of already measured parameters on long-term course of BMI (18 and 48 months) using mathematical models
Time frame: month 18, month 48
Prediction of insulin sensitivity
No additional measurement will be done. However, we will analyse the predictive impact of already measured parameters on insulin sensitivity (18 and 48 months) using mathematical models
Time frame: month 18, month 48
Prediction of energy expenditure
No additional measurement will be done. However, we will analyse the predictive impact of already measured parameters on energy expenditure (18 and 48 months) using mathematical models
Time frame: month 18, month 48
Prediction of muscle mass
No additional measurement will be done. However, we will analyse the predictive impact of already measured parameters on muscle mass (18 and 48 months) using mathematical models
Time frame: month 18, month 48
Prediction of fat mass
No additional measurement will be done. However, we will analyse the predictive impact of already measured parameters on fat mass (18 and 48 months) using mathematical models
Time frame: month 18, month 48
BMI course after a lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo
BMI (kg/m2) after the randomized control trial (RCT) (18 months) will be analyzed up to 48 months.
Time frame: month 24, month 36, month 48
changes of fatty acids during the intervention
Analysis of fatty acids at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
Time frame: month -3, month 0, month 12, month 18, month 24, month 36, month 48
changes acylcarnitines
Analysis of acylcarnitines at baseline and after 3 months of weight loss
Time frame: month -3, month 0
changes acylcarnitines
Analysis of acylcarnitines after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
Time frame: month 12, month 18, month 24, month 36, month 48
body composition
Whole body fat mass (kg, %) will be measured at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
Time frame: month -3, month 0, month 12, month 18, month 24, month 36, month 48
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