Hormonal Regulation of Body Weight Maintenance
2018年1月12日 更新者：Professor Joachim Spranger、Charite University, Berlin, Germany
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.
研究概览
研究类型
介入性
注册 (实际的)
286
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Berlin、德国、12200
- Charité
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
10年 至 90年 (孩子、成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：安慰剂
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没有干预，只有跟进
|
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实验性的：lifestyle intervention
After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults
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After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
BMI will be assessed during lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo
大体时间：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.
|
21 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Evaluation of leptin during lifestyle intervention
大体时间：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
|
month -3, month 0, month 12, month 18
|
|
Evaluation of leptin during follow up
大体时间：48 months
|
Measurement of leptin during follow up until the 48 months
|
48 months
|
|
Evaluation of catecholamines during follow up
大体时间：48 months
|
Measurement of catecholamines during follow up until the 48 months
|
48 months
|
|
Evaluation of catecholamines during lifestyle intervention
大体时间：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
|
month -3, month 0, month 12, month 18
|
|
Evaluation of cortisol during lifestyle intervention
大体时间：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
|
month -3, month 0, month 12, month 18
|
|
Evaluation of cortisol during follow up
大体时间：48 months
|
Measurement of cortisol during follow up until the 48 months
|
48 months
|
|
Evaluation of glucagon-like peptide 1 (GLP1) during lifestyle intervention
大体时间：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
|
month -3, month 0, month 12, month 18
|
|
Evaluation of GLP1 during follow up
大体时间：48 months
|
Measurement of GLP1 during follow up until the 48 months
|
48 months
|
|
Evaluation of glucose-dependent insulinotropic polypeptide (GIP) during lifestyle intervention
大体时间：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
|
month -3, month 0, month 12, month 18
|
|
Evaluation of GIP during follow up
大体时间：48 months
|
Measurement of GIP during follow up until the 48 months
|
48 months
|
|
Evaluation of thyroid hormones during lifestyle intervention
大体时间：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
|
month -3, month 0, month 12, month 18
|
|
Evaluation of thyroid hormones during follow up
大体时间：48 months
|
Measurement of thyroid hormones during follow up until the 48 months
|
48 months
|
|
Evaluation of insulin during lifestyle intervention
大体时间：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
|
month -3, month 0, month 12, month 18
|
|
Evaluation of insulin during follow up
大体时间：48 months
|
Measurement of insulin during follow up until the 48 months
|
48 months
|
|
Evaluation of insulin-like growth factor 1 (IGF1) during lifestyle intervention
大体时间：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
|
month -3, month 0, month 12, month 18
|
|
Evaluation of IGF1 during follow up
大体时间：48 months
|
Measurement of IGF1 during follow up until the 48 months
|
48 months
|
|
Evaluation of natriuretic peptide during lifestyle intervention
大体时间：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
|
month -3, month 0, month 12, month 18
|
|
Evaluation of natriuretic peptide during follow up
大体时间：48 months
|
Measurement of natriuretic peptide during follow up until the 48 months
|
48 months
|
|
Evaluation of blood pressure during lifestyle intervention
大体时间：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
|
month -3, month 0, month 12, month 18, month 24, month 36, month 48
|
|
Evaluation of free fatty acids (FFAs) during lifestyle intervention
大体时间：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
|
month -3, month 0, month 12, month 18, month 24, month 36, month 48
|
|
Evaluation of respiratory coefficient during lifestyle intervention
大体时间：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
|
month -3, month 0, month 12, month 18, month 24, month 36, month 48
|
|
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)
大体时间：month -3, month 0, month 12
|
Measurement of systemic and tissue specific changes in adipose tissue and skeletal muscle using RNA sequencing (counts)
|
month -3, month 0, month 12
|
|
Measurement of insulin sensitivity
大体时间：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)
|
month -3, month 0, month 12
|
|
Prediction of body weight regain
大体时间：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
|
month 18, month 48
|
|
Prediction of insulin sensitivity
大体时间：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
|
month 18, month 48
|
|
Prediction of energy expenditure
大体时间：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
|
month 18, month 48
|
|
Prediction of muscle mass
大体时间：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
|
month 18, month 48
|
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Prediction of fat mass
大体时间：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
|
month 18, month 48
|
|
BMI course after a lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo
大体时间：month 24, month 36, month 48
|
BMI (kg/m2) after the randomized control trial (RCT) (18 months) will be analyzed up to 48 months.
|
month 24, month 36, month 48
|
|
changes of fatty acids during the intervention
大体时间：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
|
month -3, month 0, month 12, month 18, month 24, month 36, month 48
|
|
changes acylcarnitines
大体时间：month -3, month 0
|
Analysis of acylcarnitines at baseline and after 3 months of weight loss
|
month -3, month 0
|
|
changes acylcarnitines
大体时间：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
|
month 12, month 18, month 24, month 36, month 48
|
|
body composition
大体时间：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
|
month -3, month 0, month 12, month 18, month 24, month 36, month 48
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2010年1月1日
初级完成 (实际的)
2015年12月1日
研究完成 (实际的)
2016年1月1日
研究注册日期
首次提交
2009年2月17日
首先提交符合 QC 标准的
2009年2月24日
首次发布 (估计)
2009年2月25日
研究记录更新
最后更新发布 (实际的)
2018年1月17日
上次提交的符合 QC 标准的更新
2018年1月12日
最后验证
2018年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.