Metabolism Characteristics in the Children With Narcolepsy (Narcolepsy)

Is There a Change in the Total Metabolism Over 24 Hours for Narcoleptic Children That Could Explain Their Tendency to Obesity?

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 ?

Study Overview

• Status: Unknown
• Conditions: Narcolepsy
• Intervention / Treatment: Other: Sleep and metabolism assessment

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patricia Franco, MD; Phone Number: +33 04 27 85 60 52; Email: patricia.franco@chu-lyon.fr
• Study Contact Backup: Name: Sonia Galletti; Phone Number: +33 04 27 85 77 39; Email: Sonia.galletti@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69677
    • Recruiting
    • Service d'Exploration et pathologie du sommeil, Hôpital Femme Mère Enfant
    • Contact: Patricia Franco, MD; Phone Number: +33 04 27 85 60 52; Email: patricia.franco@chu-lyon.fr
    • Contact: Sonia Galletti; Phone Number: +33 04 27 85 77 39; Email: Sonia.galletti@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Narcoleptic patients	Other: Sleep and metabolism assessment
Other: hypersomnic patients	Other: Sleep and metabolism assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of the metabolism at home	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).	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of the metabolism at hospital	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.	18 days
Basal energy expenditure	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.	18 days
Energy expenditure and diet-induced thermogenesis	Energy expenditure (kcal) measured by indirect calorimetry after lunch (with counting calories ingested).	18 days
Sympathetic activity	Estimated from IBI (Interbeat Interval) measured by Actiheart.	18 days
Food intake	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.	18 days
Fasting peptide YY		18 days
Body weight	bodyweight (kg)	18 days
Body height	Body height (cm)	18 days
Waist and hips circumference	Waist and hips circumference (cm)	18 days
Measurement of neck	Measurement of neck (cm)	18 days
Anthropometric measurements	Measurement of BMI Z-score	18 days
Appetite	appetite evaluation by visual analog scale before each meal	18 days
Hunger	hunger evaluation by visual analog scale before each meal	18 days
Fasting IL6-8 levels		18 days
Fasting adiponectin		18 days
Fasting resistin		18 days
Fasting MCP1		18 days
Fasting PostPrandial		18 days
Fasting GLP1 (glucagon-like peptide-1)		18 days
Fasting Hba1C		18 days
Body mass index z score		18 days
sleep duration		18 days

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2013
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: May 3, 2016
• First Submitted That Met QC Criteria: June 14, 2016
• First Posted (Estimate): June 15, 2016

Study Record Updates

• Last Update Posted (Actual): April 22, 2019
• Last Update Submitted That Met QC Criteria: April 19, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: metabolism; narcolepsy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disorders of Excessive Somnolence; Narcolepsy
• Other Study ID Numbers: 2012-759

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No