Is There a Change in the Total Metabolism Over 24 Hours for Narcoleptic Children That Could Explain Their Tendency to Obesity?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Determination of the metabolism at home
研究概览
简要总结
A significant weight gain and obesity are observed for most patients with narcolepsy, mainly at the beginning of the disease and narcolepsy in young children. There is no specific study on the population and the consequences of overweight in the lives of these long-term patients. Narcoleptic patients gain weight significantly at the onset of their illness. It is also known that weight gain is not related to the treatment of narcolepsy. The etiology of obesity in narcoleptic patients is not established. Several assumptions were made (physical activity, leptin diet, metabolism). The reason and the pathophysiology of overweight and obesity in this population therefore remain unclear.
In this study, potential change in the total metabolism (24h) for narcoleptic children that could explain their tendency to obesity will be assessed ?
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NARCOLEPTIC PATIENTS
- •Girl or boy age> 6 years <18 years;
- •Narcoleptic: defined by the ICSD diagnostic criteria 2 (International Classification of Sleep Disorders)
- •Beginning of the troubles there more than 6 months
- •Parental consent and agreement of the child.
- •HYPERSOMNIC PATIENTS
- •Girl or boy age> 6 years <18 years;
- •Hypersomnic : defined by the ICSD diagnostic criteria 2 (International Classification of Sleep Disorders)
- •Beginning of the troubles there more than 6 months
- •Parental consent and agreement of the child.
排除标准
- •NARCOLEPTIC PATIENTS
- •Secondary Narcolepsy;
- •Narcolepsy already treated with psychostimulant or anticataplectic;
- •Restless legs;
- •Sleep apnea syndrome;
- •Obesity known outside narcolepsy cause;
- •Absence of parental consent.
- •HYPERSOMNIC PATIENTS
- •symptomatic or secondary hypersomnia;
- •Hypersomnia already treated psychostimulant or anticataplectic; Restless legs;
- •Sleep apnea syndrome;
- •Pathology neurological, psychiatric, endocrine or concurrent;
- •Lack of parental consent
研究组 & 干预措施
Narcoleptic patients
干预措施: Sleep and metabolism assessment (Other)
hypersomnic patients
干预措施: Sleep and metabolism assessment (Other)
结局指标
主要结局
Determination of the metabolism at home
时间窗: 15 days
Total energy expenditure in kilocalories per minute, including basal metabolic rate (MET) metabolism related to the activity (EEA), and physical activity (PA) measured by accelerometer (Actical) evaluated at home (15 days including scholar and non-scholar days).
次要结局
- Body mass index z score(18 days)
- sleep duration(18 days)
- Fasting peptide YY(18 days)
- Body weight(18 days)
- Body height(18 days)
- Fasting PostPrandial(18 days)
- Anthropometric measurements(18 days)
- Determination of the metabolism at hospital(18 days)
- Basal energy expenditure(18 days)
- Energy expenditure and diet-induced thermogenesis(18 days)
- Sympathetic activity(18 days)
- Food intake(18 days)
- Waist and hips circumference(18 days)
- Measurement of neck(18 days)
- Appetite(18 days)
- Hunger(18 days)
- Fasting IL6-8 levels(18 days)
- Fasting adiponectin(18 days)
- Fasting resistin(18 days)
- Fasting MCP1(18 days)
- Fasting GLP1 (glucagon-like peptide-1)(18 days)
- Fasting Hba1C(18 days)