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Completed

NCT Number: NCT02799849

Metabolism Characteristics in the Children With Narcolepsy

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 ?

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bron, 69677, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep and metabolism assessment

Other

Primary outcomes

  1. Determination of the metabolism at home

    Time frame: 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 outcomes

  1. Determination of the metabolism at hospital

    Time frame: 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.

  2. Basal energy expenditure

    Time frame: 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.

  3. Energy expenditure and diet-induced thermogenesis

    Time frame: 18 days

    Energy expenditure (kcal) measured by indirect calorimetry after lunch (with counting calories ingested).

  4. Sympathetic activity

    Time frame: 18 days

    Estimated from IBI (Interbeat Interval) measured by Actiheart.

  5. Food intake

    Time frame: 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.

  6. Fasting peptide YY

    Time frame: 18 days

  7. Body weight

    Time frame: 18 days

    bodyweight (kg)

  8. Body height

    Time frame: 18 days

    Body height (cm)

  9. Waist and hips circumference

    Time frame: 18 days

    Waist and hips circumference (cm)

  10. Measurement of neck

    Time frame: 18 days

    Measurement of neck (cm)

  11. Anthropometric measurements

    Time frame: 18 days

    Measurement of BMI Z-score

  12. Appetite

    Time frame: 18 days

    appetite evaluation by visual analog scale before each meal

  13. Hunger

    Time frame: 18 days

    hunger evaluation by visual analog scale before each meal

  14. Fasting IL6-8 levels

    Time frame: 18 days

  15. Fasting adiponectin

    Time frame: 18 days

  16. Fasting resistin

    Time frame: 18 days

  17. Fasting MCP1

    Time frame: 18 days

  18. Fasting PostPrandial

    Time frame: 18 days

  19. Fasting GLP1 (glucagon-like peptide-1)

    Time frame: 18 days

  20. Fasting Hba1C

    Time frame: 18 days

  21. Body mass index z score

    Time frame: 18 days

  22. sleep duration

    Time frame: 18 days

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: Narcolepsy

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jun 15, 2016
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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