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Hormonal Regulation of Body Weight Maintenance

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ClinicalTrials.gov Identifier: NCT00850629
Recruitment Status : Completed
First Posted : February 25, 2009
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Obesity Weight Loss Weight Gain Hormone Disturbance Adipose Tissue Insulin Resistance Skeletal Muscle Behavioral: multimodal lifestyle intervention Behavioral: placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hormonal Regulation of Body Weight Maintenance
Actual Study Start Date : January 2010
Primary Completion Date : December 2015
Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: placebo
Placebo
Behavioral: placebo
no intervention, only follow up
Experimental: lifestyle intervention
After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults
Behavioral: multimodal lifestyle intervention
After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults


Outcome Measures

Primary Outcome Measures :
  1. BMI will be assessed during lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo [ Time Frame: 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 :
  1. Evaluation of leptin during lifestyle intervention [ Time Frame: 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

  2. Evaluation of leptin during follow up [ Time Frame: 48 months ]
    Measurement of leptin during follow up until the 48 months

  3. Evaluation of catecholamines during follow up [ Time Frame: 48 months ]
    Measurement of catecholamines during follow up until the 48 months

  4. Evaluation of catecholamines during lifestyle intervention [ Time Frame: 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

  5. Evaluation of cortisol during lifestyle intervention [ Time Frame: 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

  6. Evaluation of cortisol during follow up [ Time Frame: 48 months ]
    Measurement of cortisol during follow up until the 48 months

  7. Evaluation of glucagon-like peptide 1 (GLP1) during lifestyle intervention [ Time Frame: 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

  8. Evaluation of GLP1 during follow up [ Time Frame: 48 months ]
    Measurement of GLP1 during follow up until the 48 months

  9. Evaluation of glucose-dependent insulinotropic polypeptide (GIP) during lifestyle intervention [ Time Frame: 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

  10. Evaluation of GIP during follow up [ Time Frame: 48 months ]
    Measurement of GIP during follow up until the 48 months

  11. Evaluation of thyroid hormones during lifestyle intervention [ Time Frame: 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

  12. Evaluation of thyroid hormones during follow up [ Time Frame: 48 months ]
    Measurement of thyroid hormones during follow up until the 48 months

  13. Evaluation of insulin during lifestyle intervention [ Time Frame: 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

  14. Evaluation of insulin during follow up [ Time Frame: 48 months ]
    Measurement of insulin during follow up until the 48 months

  15. Evaluation of insulin-like growth factor 1 (IGF1) during lifestyle intervention [ Time Frame: 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

  16. Evaluation of IGF1 during follow up [ Time Frame: 48 months ]
    Measurement of IGF1 during follow up until the 48 months

  17. Evaluation of natriuretic peptide during lifestyle intervention [ Time Frame: 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

  18. Evaluation of natriuretic peptide during follow up [ Time Frame: 48 months ]
    Measurement of natriuretic peptide during follow up until the 48 months

  19. Evaluation of blood pressure during lifestyle intervention [ Time Frame: 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

  20. Evaluation of free fatty acids (FFAs) during lifestyle intervention [ Time Frame: 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

  21. Evaluation of respiratory coefficient during lifestyle intervention [ Time Frame: 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

  22. 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) [ Time Frame: month -3, month 0, month 12 ]
    Measurement of systemic and tissue specific changes in adipose tissue and skeletal muscle using RNA sequencing (counts)

  23. Measurement of insulin sensitivity [ Time Frame: 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)

  24. Prediction of body weight regain [ Time Frame: 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

  25. Prediction of insulin sensitivity [ Time Frame: 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

  26. Prediction of energy expenditure [ Time Frame: 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

  27. Prediction of muscle mass [ Time Frame: 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

  28. Prediction of fat mass [ Time Frame: 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

  29. BMI course after a lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo [ Time Frame: month 24, month 36, month 48 ]
    BMI (kg/m2) after the randomized control trial (RCT) (18 months) will be analyzed up to 48 months.

  30. changes of fatty acids during the intervention [ Time Frame: 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

  31. changes acylcarnitines [ Time Frame: month -3, month 0 ]
    Analysis of acylcarnitines at baseline and after 3 months of weight loss

  32. changes acylcarnitines [ Time Frame: 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

  33. body composition [ Time Frame: 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850629


Locations
Germany
Charite
Berlin, Germany, 12200
Sponsors and Collaborators
Charite University, Berlin, Germany
German Research Foundation
Investigators
Principal Investigator: Knut Mai, Prof Charite
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Joachim Spranger, Professor, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00850629     History of Changes
Other Study ID Numbers: EA2/017/09
First Posted: February 25, 2009    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Professor Joachim Spranger, Charite University, Berlin, Germany:
weight regain
endocrine counterregulation

Additional relevant MeSH terms:
Body Weight
Weight Loss
Insulin Resistance
Weight Gain
Endocrine System Diseases
Signs and Symptoms
Body Weight Changes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases