Back to resultsHormonal Regulation of Body Weight Maintenance
Primary Purpose
Obesity, Weight Loss, Weight Gain
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
multimodal lifestyle intervention
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring weight regain, endocrine counterregulation
Eligibility Criteria
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
Sites / Locations
- Charite
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
placebo
lifestyle intervention
Arm Description
Placebo
After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Evaluation of leptin during follow up
Measurement of leptin during follow up until the 48 months
Evaluation of catecholamines during follow up
Measurement of catecholamines during follow up until the 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
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
Evaluation of cortisol during follow up
Measurement of cortisol during follow up until the 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
Evaluation of GLP1 during follow up
Measurement of GLP1 during follow up until the 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
Evaluation of GIP during follow up
Measurement of GIP during follow up until the 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
Evaluation of thyroid hormones during follow up
Measurement of thyroid hormones during follow up until the 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
Evaluation of insulin during follow up
Measurement of insulin during follow up until the 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
Evaluation of IGF1 during follow up
Measurement of IGF1 during follow up until the 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
Evaluation of natriuretic peptide during follow up
Measurement of natriuretic peptide during follow up until the 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
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
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
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)
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)
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
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
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
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
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
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.
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
changes acylcarnitines
Analysis of acylcarnitines at baseline and after 3 months of weight loss
changes acylcarnitines
Analysis of acylcarnitines after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
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
Full Information
NCT ID
NCT00850629
First Posted
February 17, 2009
Last Updated
January 12, 2018
Sponsor
Charite University, Berlin, Germany
Collaborators
German Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00850629
Brief Title
Hormonal Regulation of Body Weight Maintenance
Official Title
Hormonal Regulation of Body Weight Maintenance
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2010 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
German Research Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss, Weight Gain, Hormone Disturbance, Adipose Tissue, Insulin Resistance, Skeletal Muscle
Keywords
weight regain, endocrine counterregulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
286 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
lifestyle intervention
Arm Type
Experimental
Arm Description
After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults
Intervention Type
Behavioral
Intervention Name(s)
multimodal lifestyle intervention
Intervention Description
After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults
Intervention Type
Behavioral
Intervention Name(s)
placebo
Intervention Description
no intervention, only follow up
Primary Outcome Measure Information:
Title
BMI will be assessed during lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo
Description
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
Secondary Outcome Measure Information:
Title
Evaluation of leptin during lifestyle intervention
Description
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
Title
Evaluation of leptin during follow up
Description
Measurement of leptin during follow up until the 48 months
Time Frame
48 months
Title
Evaluation of catecholamines during follow up
Description
Measurement of catecholamines during follow up until the 48 months
Time Frame
48 months
Title
Evaluation of catecholamines during lifestyle intervention
Description
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
Title
Evaluation of cortisol during lifestyle intervention
Description
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
Title
Evaluation of cortisol during follow up
Description
Measurement of cortisol during follow up until the 48 months
Time Frame
48 months
Title
Evaluation of glucagon-like peptide 1 (GLP1) during lifestyle intervention
Description
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
Title
Evaluation of GLP1 during follow up
Description
Measurement of GLP1 during follow up until the 48 months
Time Frame
48 months
Title
Evaluation of glucose-dependent insulinotropic polypeptide (GIP) during lifestyle intervention
Description
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
Title
Evaluation of GIP during follow up
Description
Measurement of GIP during follow up until the 48 months
Time Frame
48 months
Title
Evaluation of thyroid hormones during lifestyle intervention
Description
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
Title
Evaluation of thyroid hormones during follow up
Description
Measurement of thyroid hormones during follow up until the 48 months
Time Frame
48 months
Title
Evaluation of insulin during lifestyle intervention
Description
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
Title
Evaluation of insulin during follow up
Description
Measurement of insulin during follow up until the 48 months
Time Frame
48 months
Title
Evaluation of insulin-like growth factor 1 (IGF1) during lifestyle intervention
Description
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
Title
Evaluation of IGF1 during follow up
Description
Measurement of IGF1 during follow up until the 48 months
Time Frame
48 months
Title
Evaluation of natriuretic peptide during lifestyle intervention
Description
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
Title
Evaluation of natriuretic peptide during follow up
Description
Measurement of natriuretic peptide during follow up until the 48 months
Time Frame
48 months
Title
Evaluation of blood pressure during lifestyle intervention
Description
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
Title
Evaluation of free fatty acids (FFAs) during lifestyle intervention
Description
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
Title
Evaluation of respiratory coefficient during lifestyle intervention
Description
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
Title
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)
Description
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
Title
Measurement of insulin sensitivity
Description
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
Title
Prediction of body weight regain
Description
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
Title
Prediction of insulin sensitivity
Description
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
Title
Prediction of energy expenditure
Description
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
Title
Prediction of muscle mass
Description
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
Title
Prediction of fat mass
Description
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
Title
BMI course after a lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo
Description
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
Title
changes of fatty acids during the intervention
Description
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
Title
changes acylcarnitines
Description
Analysis of acylcarnitines at baseline and after 3 months of weight loss
Time Frame
month -3, month 0
Title
changes acylcarnitines
Description
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
Title
body composition
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Knut Mai, Prof
Organizational Affiliation
Charite
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite
City
Berlin
ZIP/Postal Code
12200
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35897098
Citation
Li L, Soll D, Leupelt V, Spranger J, Mai K. Weight loss-induced improvement of body weight and insulin sensitivity is not amplified by a subsequent 12-month weight maintenance intervention but is predicted by adaption of adipose atrial natriuretic peptide system: 48-month results of a randomized controlled trial. BMC Med. 2022 Jul 28;20(1):238. doi: 10.1186/s12916-022-02435-9.
Results Reference
derived
PubMed Identifier
35346256
Citation
Soll D, Gawron J, Pletsch-Borba L, Spranger J, Mai K. Long-term impact of the metabolic status on weight loss-induced health benefits. Nutr Metab (Lond). 2022 Mar 28;19(1):25. doi: 10.1186/s12986-022-00660-w.
Results Reference
derived
PubMed Identifier
34611132
Citation
Li L, Spranger L, Stobaus N, Beer F, Decker AM, Wernicke C, Brachs S, Brachs M, Spranger J, Mai K. Fetuin-B, a potential link of liver-adipose tissue cross talk during diet-induced weight loss-weight maintenance. Nutr Diabetes. 2021 Oct 5;11(1):31. doi: 10.1038/s41387-021-00174-z.
Results Reference
derived
PubMed Identifier
33065163
Citation
Li L, Spranger L, Soll D, Beer F, Brachs M, Spranger J, Mai K. Metabolic impact of weight loss induced reduction of adipose ACE-2 - Potential implication in COVID-19 infections? Metabolism. 2020 Dec;113:154401. doi: 10.1016/j.metabol.2020.154401. Epub 2020 Oct 13.
Results Reference
derived
PubMed Identifier
30552109
Citation
Brachs S, Polack J, Brachs M, Jahn-Hofmann K, Elvert R, Pfenninger A, Barenz F, Margerie D, Mai K, Spranger J, Kannt A. Genetic Nicotinamide N-Methyltransferase (Nnmt) Deficiency in Male Mice Improves Insulin Sensitivity in Diet-Induced Obesity but Does Not Affect Glucose Tolerance. Diabetes. 2019 Mar;68(3):527-542. doi: 10.2337/db18-0780. Epub 2018 Dec 14.
Results Reference
derived
PubMed Identifier
30389745
Citation
Mai K, Li L, Wiegand S, Brachs M, Leupelt V, Ernert A, Kuhnen P, Hubner N, Robinson P, Chen W, Krude H, Spranger J. An Integrated Understanding of the Molecular Mechanisms of How Adipose Tissue Metabolism Affects Long-term Body Weight Maintenance. Diabetes. 2019 Jan;68(1):57-65. doi: 10.2337/db18-0440. Epub 2018 Nov 2.
Results Reference
derived
PubMed Identifier
27298729
Citation
Bau AM, Ernert A, Krude H, Wiegand S. Hormonal regulatory mechanisms in obese children and adolescents after previous weight reduction with a lifestyle intervention: maintain - paediatric part - a RCT from 2009-15. BMC Obes. 2016 Jun 10;3:29. doi: 10.1186/s40608-016-0110-8. eCollection 2016.
Results Reference
derived
PubMed Identifier
27173472
Citation
Brachs M, Wiegand S, Leupelt V, Ernert A, Kintscher U, Jumpertz von Schwarzenberg R, Decker AM, Bobbert T, Hubner N, Chen W, Krude H, Spranger J, Mai K. ANP system activity predicts variability of fat mass reduction and insulin sensitivity during weight loss. Metabolism. 2016 Jun;65(6):935-43. doi: 10.1016/j.metabol.2016.03.013. Epub 2016 Apr 7.
Results Reference
derived
PubMed Identifier
25576647
Citation
Weygandt M, Mai K, Dommes E, Ritter K, Leupelt V, Spranger J, Haynes JD. Impulse control in the dorsolateral prefrontal cortex counteracts post-diet weight regain in obesity. Neuroimage. 2015 Apr 1;109:318-27. doi: 10.1016/j.neuroimage.2014.12.073. Epub 2015 Jan 7.
Results Reference
derived
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Hormonal Regulation of Body Weight Maintenance
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