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Metabolism Characteristics in the Children With Narcolepsy

NCT ID: NCT02799849

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-20

Study Completion Date

2018-09-30

Brief Summary

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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

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Conditions

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Narcolepsy

Keywords

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narcolepsy metabolism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Narcoleptic patients

Group Type OTHER

Sleep and metabolism assessment

Intervention Type OTHER

hypersomnic patients

Group Type OTHER

Sleep and metabolism assessment

Intervention Type OTHER

Interventions

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Sleep and metabolism assessment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service d'Exploration et pathologie du sommeil, Hôpital Femme Mère Enfant

Bron, , France

Site Status

Countries

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France

Other Identifiers

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2012-759

Identifier Type: -

Identifier Source: org_study_id