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Metabolism Characteristics in the Children With Narcolepsy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02799849
Acronym
Narcolepsy
Enrollment
24
Registered
2016-06-15
Start date
2013-12-20
Completion date
2018-09-30
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Narcolepsy

Keywords

narcolepsy, metabolism

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 ?

Interventions

OTHERSleep and metabolism assessment

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Determination of the metabolism at home15 daysTotal 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

MeasureTime frameDescription
Basal energy expenditure18 daysThe 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 thermogenesis18 daysEnergy expenditure (kcal) measured by indirect calorimetry after lunch (with counting calories ingested).
Sympathetic activity18 daysEstimated from IBI (Interbeat Interval) measured by Actiheart.
Food intake18 daysCaloric 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 YY18 days
Body weight18 daysbodyweight (kg)
Body height18 daysBody height (cm)
Waist and hips circumference18 daysWaist and hips circumference (cm)
Measurement of neck18 daysMeasurement of neck (cm)
Anthropometric measurements18 daysMeasurement of BMI Z-score
Determination of the metabolism at hospital18 daysTotal 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.
Hunger18 dayshunger evaluation by visual analog scale before each meal
Fasting IL6-8 levels18 days
Fasting adiponectin18 days
Fasting resistin18 days
Fasting MCP118 days
Fasting PostPrandial18 days
Fasting GLP1 (glucagon-like peptide-1)18 days
Fasting Hba1C18 days
Body mass index z score18 days
sleep duration18 days
Appetite18 daysappetite evaluation by visual analog scale before each meal

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026