Hormonal Regulation of Body Weight Maintenance
- Conditions
- Insulin ResistanceObesityHormone DisturbanceWeight LossWeight GainAdipose TissueSkeletal Muscle
- Interventions
- Behavioral: placeboBehavioral: multimodal lifestyle intervention
- Registration Number
- NCT00850629
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 286
- BMI > 27 kg/m2 (adults)
-
weight loss of more than 5kg in the last 2 months
-
pregnancy, breastfeeding
-
patients with:
- severe heart failure
- impaired hepatic or renal function
- anaemia
- disturbed coagulation (biopsies will not be taken in those subjects)
- infection, malabsorption
- severe hypertension
- cancer within the last 5 years
- eating disorders or any other psychiatric condition that would interact with the trial intervention
- any other endocrine disorder
-
changes of smoking habits or diets within the last 3 months prior to study inclusion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo Placebo lifestyle intervention multimodal lifestyle intervention After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults
- Primary Outcome Measures
Name Time Method BMI will be assessed during lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo 21 months 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.
- Secondary Outcome Measures
Name Time Method Evaluation of catecholamines during follow up 48 months Measurement of catecholamines during follow up until the 48 months
Evaluation of leptin during lifestyle intervention month -3, month 0, month 12, month 18 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
Evaluation of catecholamines during lifestyle intervention month -3, month 0, month 12, month 18 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
Evaluation of glucagon-like peptide 1 (GLP1) during lifestyle intervention month -3, month 0, month 12, month 18 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
Evaluation of leptin during follow up 48 months Measurement of leptin during follow up until the 48 months
Evaluation of glucose-dependent insulinotropic polypeptide (GIP) during lifestyle intervention month -3, month 0, month 12, month 18 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
Evaluation of thyroid hormones during follow up 48 months Measurement of thyroid hormones during follow up until the 48 months
Evaluation of insulin during lifestyle intervention month -3, month 0, month 12, month 18 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
Evaluation of cortisol during follow up 48 months Measurement of cortisol during follow up until the 48 months
Evaluation of IGF1 during follow up 48 months Measurement of IGF1 during follow up until the 48 months
Evaluation of cortisol during lifestyle intervention month -3, month 0, month 12, month 18 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
Evaluation of GLP1 during follow up 48 months Measurement of GLP1 during follow up until the 48 months
Evaluation of GIP during follow up 48 months Measurement of GIP during follow up until the 48 months
Evaluation of thyroid hormones during lifestyle intervention month -3, month 0, month 12, month 18 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
Evaluation of insulin during follow up 48 months Measurement of insulin during follow up until the 48 months
Evaluation of natriuretic peptide during lifestyle intervention month -3, month 0, month 12, month 18 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
Evaluation of natriuretic peptide during follow up 48 months Measurement of natriuretic peptide during follow up until the 48 months
Evaluation of respiratory coefficient during lifestyle intervention month -3, month 0, month 12, month 18, month 24, month 36, month 48 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
Prediction of body weight regain month 18, month 48 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
Evaluation of insulin-like growth factor 1 (IGF1) during lifestyle intervention month -3, month 0, month 12, month 18 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
Prediction of energy expenditure month 18, month 48 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
body composition month -3, month 0, month 12, month 18, month 24, month 36, month 48 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
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) month -3, month 0, month 12 Measurement of systemic and tissue specific changes in adipose tissue and skeletal muscle using RNA sequencing (counts)
Prediction of insulin sensitivity month 18, month 48 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
changes acylcarnitines month 12, month 18, month 24, month 36, month 48 Analysis of acylcarnitines after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
Evaluation of blood pressure during lifestyle intervention month -3, month 0, month 12, month 18, month 24, month 36, month 48 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
Evaluation of free fatty acids (FFAs) during lifestyle intervention month -3, month 0, month 12, month 18, month 24, month 36, month 48 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
Measurement of insulin sensitivity month -3, month 0, month 12 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)
Prediction of muscle mass month 18, month 48 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
Prediction of fat mass month 18, month 48 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
BMI course after a lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo month 24, month 36, month 48 BMI (kg/m2) after the randomized control trial (RCT) (18 months) will be analyzed up to 48 months.
changes of fatty acids during the intervention month -3, month 0, month 12, month 18, month 24, month 36, month 48 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
Trial Locations
- Locations (1)
Charite
🇩🇪Berlin, Germany