Metabolism Characteristics in the Children With Narcolepsy

Not Applicable

• Conditions: Narcolepsy
• Interventions: Other: Sleep and metabolism assessment

• Registration Number: NCT02799849
• Lead Sponsor: Hospices Civils de Lyon

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 ?

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-12-20
• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-15
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-19
• Last Update Posted: 2019-04-22
• Primary Completion: 2019-11
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hypersomnic patients	Sleep and metabolism assessment	-
Narcoleptic patients	Sleep and metabolism assessment	-

Primary Outcome Measures

Name	Time	Method
Determination of the metabolism at home	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).

Secondary Outcome Measures

Name	Time	Method
sleep duration	18 days
Body mass index z score	18 days
Body height	18 days	Body height (cm)
Fasting PostPrandial	18 days
Anthropometric measurements	18 days	Measurement of BMI Z-score
Determination of the metabolism at hospital	18 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 hospital over 24 hours.
Basal energy expenditure	18 days	The basal metabolism (MET) measured by accelerometer (Actical, BodyMedia SW Actiheart) will be compared to the values of energy expenditure (kcal) measured by indirect calorimetry fasting.
Energy expenditure and diet-induced thermogenesis	18 days	Energy expenditure (kcal) measured by indirect calorimetry after lunch (with counting calories ingested).
Sympathetic activity	18 days	Estimated from IBI (Interbeat Interval) measured by Actiheart.
Food intake	18 days	Caloric intake evaluation (kcal per day) during hospitalization (food intake recording) and at home during three days ( two days during the week and one day during the week-end) evaluated by questionnary.
Fasting peptide YY	18 days
Body weight	18 days	bodyweight (kg)
Waist and hips circumference	18 days	Waist and hips circumference (cm)
Measurement of neck	18 days	Measurement of neck (cm)
Fasting resistin	18 days
Appetite	18 days	appetite evaluation by visual analog scale before each meal
Hunger	18 days	hunger evaluation by visual analog scale before each meal
Fasting IL6-8 levels	18 days
Fasting adiponectin	18 days
Fasting MCP1	18 days
Fasting GLP1 (glucagon-like peptide-1)	18 days
Fasting Hba1C	18 days

Trial Locations

Locations (1)

Service d'Exploration et pathologie du sommeil, Hôpital Femme Mère Enfant; 🇫🇷 Bron, France