Clinical trial NCT02799849: Metabolism Characteristics in the Children With Narcolepsy
Official title: Is There a Change in the Total Metabolism Over 24 Hours for Narcoleptic Children That Could Explain Their Tendency to Obesity?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Narcolepsy
Keywords: narcolepsy
metabolism
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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 ?


Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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

Primary outcomes:
measure: Determination of the metabolism at home
timeFrame: 15 days
Secondary outcomes:
measure: Determination of the metabolism at hospital
timeFrame: 18 days
measure: Basal energy expenditure
timeFrame: 18 days
measure: Energy expenditure and diet-induced thermogenesis
timeFrame: 18 days
measure: Sympathetic activity
timeFrame: 18 days
measure: Food intake
timeFrame: 18 days
measure: Fasting peptide YY
timeFrame: 18 days
measure: Body weight
timeFrame: 18 days
measure: Body height
timeFrame: 18 days
measure: Waist and hips circumference
timeFrame: 18 days
measure: Measurement of neck
timeFrame: 18 days
measure: Anthropometric measurements
timeFrame: 18 days
measure: Appetite
timeFrame: 18 days
measure: Hunger
timeFrame: 18 days
measure: Fasting IL6-8 levels
timeFrame: 18 days
measure: Fasting adiponectin
timeFrame: 18 days
measure: Fasting resistin
timeFrame: 18 days
measure: Fasting MCP1
timeFrame: 18 days
measure: Fasting PostPrandial
timeFrame: 18 days
measure: Fasting GLP1 (glucagon-like peptide-1)
timeFrame: 18 days
measure: Fasting Hba1C
timeFrame: 18 days
measure: Body mass index z score
timeFrame: 18 days
measure: sleep duration
timeFrame: 18 days
Other outcomes:
Locations:
city: Bron
country: France
facility: Service d'Exploration et pathologie du sommeil, Hôpital Femme Mère Enfant
Study officials:
References: