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Completed

NCT Number: NCT00850629

Hormonal Regulation of Body Weight Maintenance

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.

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Key information

Conditions

Obesity Adipose Tissue Body Weight Body Weight Changes Endocrine System Diseases Glucose Metabolism Disorders Hormone Disturbance Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Skeletal Muscle Weight Gain Weight Loss

Age range

10 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charite

Berlin, 12200, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multimodal lifestyle intervention

Behavioral

After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults

Placebo

Behavioral

no intervention, only follow up

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • German Research Foundation

Registry information

Important dates

Study start
2010
Primary completion
2015
Study completion
2016
First posted
Feb 25, 2009
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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