NCT00850629已完成不适用
Hormonal Regulation of Body Weight Maintenance
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 286
- 试验地点
- 2
- 主要终点
- BMI will be assessed during lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI > 27 kg/m2 (adults)
排除标准
- •weight loss of more than 5kg in the last 2 months
- •pregnancy, breastfeeding
- •patients with:
- •severe heart failure
- •impaired hepatic or renal function
- •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
结局指标
主要结局
BMI will be assessed during lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo
时间窗: 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.
次要结局
- Evaluation of catecholamines during follow up(48 months)
- Evaluation of leptin during lifestyle intervention(month -3, month 0, month 12, month 18)
- Evaluation of catecholamines during lifestyle intervention(month -3, month 0, month 12, month 18)
- Evaluation of glucagon-like peptide 1 (GLP1) during lifestyle intervention(month -3, month 0, month 12, month 18)
- Evaluation of leptin during follow up(48 months)
- Evaluation of glucose-dependent insulinotropic polypeptide (GIP) during lifestyle intervention(month -3, month 0, month 12, month 18)
- Evaluation of thyroid hormones during follow up(48 months)
- Evaluation of insulin during lifestyle intervention(month -3, month 0, month 12, month 18)
- Evaluation of cortisol during follow up(48 months)
- Evaluation of IGF1 during follow up(48 months)
- Evaluation of cortisol during lifestyle intervention(month -3, month 0, month 12, month 18)
- Evaluation of GLP1 during follow up(48 months)
- Evaluation of GIP during follow up(48 months)
- Evaluation of thyroid hormones during lifestyle intervention(month -3, month 0, month 12, month 18)
- Evaluation of insulin during follow up(48 months)
- Evaluation of natriuretic peptide during lifestyle intervention(month -3, month 0, month 12, month 18)
- Evaluation of natriuretic peptide during follow up(48 months)
- Evaluation of respiratory coefficient during lifestyle intervention(month -3, month 0, month 12, month 18, month 24, month 36, month 48)
- Prediction of body weight regain(month 18, month 48)
- Evaluation of insulin-like growth factor 1 (IGF1) during lifestyle intervention(month -3, month 0, month 12, month 18)
- Prediction of energy expenditure(month 18, month 48)
- body composition(month -3, month 0, month 12, month 18, month 24, month 36, month 48)
- changes acylcarnitines(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)(month -3, month 0, month 12)
- Prediction of insulin sensitivity(month 18, month 48)
- Evaluation of blood pressure during lifestyle intervention(month -3, month 0, month 12, month 18, month 24, month 36, month 48)
- Evaluation of free fatty acids (FFAs) during lifestyle intervention(month -3, month 0, month 12, month 18, month 24, month 36, month 48)
- Measurement of insulin sensitivity(month -3, month 0, month 12)
- Prediction of muscle mass(month 18, month 48)
- Prediction of fat mass(month 18, month 48)
- BMI course after a lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo(month 24, month 36, month 48)
- changes of fatty acids during the intervention(month -3, month 0, month 12, month 18, month 24, month 36, month 48)
研究者
Professor Joachim Spranger
Professor
Charite University, Berlin, Germany
研究点 (2)
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