Metabolism Characteristics in the Children With Narcolepsy

Narcolepsy Clinical Trial

— Narcolepsy  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02799849
• Other study ID #: 2012-759
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2013
• Est. completion date: November 2019

Study information

• Verified date: April 2019
• Source: Hospices Civils de Lyon
• Contact: Patricia FRANCO, MD
• Phone: 04 27 85 60 52
• Email: patricia.franco[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Narcolepsy

Intervention

Other:
• Sleep and metabolism assessment

Locations

Country	Name	City	State
France	Service d'Exploration et pathologie du sommeil, Hôpital Femme Mère Enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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