Hormonal Regulation of Body Weight Maintenance

Obesity Clinical Trial

Official title:

Hormonal Regulation of Body Weight Maintenance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00850629
• Other study ID #: EA2/017/09
• Status: Completed
• Phase: N/A
• First received: February 17, 2009
• Last updated: January 12, 2018
• Start date: January 2010
• Est. completion date: January 2016

Study information

• Verified date: January 2018
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 90 Years

Eligibility

Inclusion Criteria:

• BMI > 27 kg/m2 (adults)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Adipose Tissue
• Body Weight
• Endocrine System Diseases
• Hormone Disturbance
• Insulin Resistance
• Obesity
• Skeletal Muscle
• Weight Gain
• Weight Loss

Intervention

Behavioral:
• multimodal lifestyle intervention
After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults
• placebo
no intervention, only follow up

Locations

Country	Name	City	State
Germany	Charite	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	21 months
Secondary	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	month -3, month 0, month 12, month 18
Secondary	Evaluation of leptin during follow up	Measurement of leptin during follow up until the 48 months	48 months
Secondary	Evaluation of catecholamines during follow up	Measurement of catecholamines during follow up until the 48 months	48 months
Secondary	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	month -3, month 0, month 12, month 18
Secondary	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	month -3, month 0, month 12, month 18
Secondary	Evaluation of cortisol during follow up	Measurement of cortisol during follow up until the 48 months	48 months
Secondary	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	month -3, month 0, month 12, month 18
Secondary	Evaluation of GLP1 during follow up	Measurement of GLP1 during follow up until the 48 months	48 months
Secondary	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	month -3, month 0, month 12, month 18
Secondary	Evaluation of GIP during follow up	Measurement of GIP during follow up until the 48 months	48 months
Secondary	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	month -3, month 0, month 12, month 18
Secondary	Evaluation of thyroid hormones during follow up	Measurement of thyroid hormones during follow up until the 48 months	48 months
Secondary	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	month -3, month 0, month 12, month 18
Secondary	Evaluation of insulin during follow up	Measurement of insulin during follow up until the 48 months	48 months
Secondary	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	month -3, month 0, month 12, month 18
Secondary	Evaluation of IGF1 during follow up	Measurement of IGF1 during follow up until the 48 months	48 months
Secondary	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	month -3, month 0, month 12, month 18
Secondary	Evaluation of natriuretic peptide during follow up	Measurement of natriuretic peptide during follow up until the 48 months	48 months
Secondary	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	month -3, month 0, month 12, month 18, month 24, month 36, month 48
Secondary	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	month -3, month 0, month 12, month 18, month 24, month 36, month 48
Secondary	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	month -3, month 0, month 12, month 18, month 24, month 36, month 48
Secondary	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)	month -3, month 0, month 12
Secondary	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)	month -3, month 0, month 12
Secondary	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	month 18, month 48
Secondary	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	month 18, month 48
Secondary	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	month 18, month 48
Secondary	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	month 18, month 48
Secondary	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	month 18, month 48
Secondary	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.	month 24, month 36, month 48
Secondary	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	month -3, month 0, month 12, month 18, month 24, month 36, month 48
Secondary	changes acylcarnitines	Analysis of acylcarnitines at baseline and after 3 months of weight loss	month -3, month 0
Secondary	changes acylcarnitines	Analysis of acylcarnitines after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up	month 12, month 18, month 24, month 36, month 48
Secondary	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	month -3, month 0, month 12, month 18, month 24, month 36, month 48