Metabolism Characteristics in the Children With Narcolepsy (Narcolepsy)
Primary Purpose
Narcolepsy
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sleep and metabolism assessment
Sponsored by
About this trial
This is an interventional basic science trial for Narcolepsy focused on measuring narcolepsy, metabolism
Eligibility Criteria
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
Sites / Locations
- Service d'Exploration et pathologie du sommeil, Hôpital Femme Mère EnfantRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Narcoleptic patients
hypersomnic patients
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
Energy expenditure and diet-induced thermogenesis
Energy expenditure (kcal) measured by indirect calorimetry after lunch (with counting calories ingested).
Sympathetic activity
Estimated from IBI (Interbeat Interval) measured by Actiheart.
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.
Fasting peptide YY
Body weight
bodyweight (kg)
Body height
Body height (cm)
Waist and hips circumference
Waist and hips circumference (cm)
Measurement of neck
Measurement of neck (cm)
Anthropometric measurements
Measurement of BMI Z-score
Appetite
appetite evaluation by visual analog scale before each meal
Hunger
hunger evaluation by visual analog scale before each meal
Fasting IL6-8 levels
Fasting adiponectin
Fasting resistin
Fasting MCP1
Fasting PostPrandial
Fasting GLP1 (glucagon-like peptide-1)
Fasting Hba1C
Body mass index z score
sleep duration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02799849
Brief Title
Metabolism Characteristics in the Children With Narcolepsy
Acronym
Narcolepsy
Official Title
Is There a Change in the Total Metabolism Over 24 Hours for Narcoleptic Children That Could Explain Their Tendency to Obesity?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 20, 2013 (Actual)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 ?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcolepsy
Keywords
narcolepsy, metabolism
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Narcoleptic patients
Arm Type
Other
Arm Title
hypersomnic patients
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Sleep and metabolism assessment
Primary Outcome Measure Information:
Title
Determination of the metabolism at home
Description
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).
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Determination of the metabolism at hospital
Description
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.
Time Frame
18 days
Title
Basal energy expenditure
Description
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.
Time Frame
18 days
Title
Energy expenditure and diet-induced thermogenesis
Description
Energy expenditure (kcal) measured by indirect calorimetry after lunch (with counting calories ingested).
Time Frame
18 days
Title
Sympathetic activity
Description
Estimated from IBI (Interbeat Interval) measured by Actiheart.
Time Frame
18 days
Title
Food intake
Description
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.
Time Frame
18 days
Title
Fasting peptide YY
Time Frame
18 days
Title
Body weight
Description
bodyweight (kg)
Time Frame
18 days
Title
Body height
Description
Body height (cm)
Time Frame
18 days
Title
Waist and hips circumference
Description
Waist and hips circumference (cm)
Time Frame
18 days
Title
Measurement of neck
Description
Measurement of neck (cm)
Time Frame
18 days
Title
Anthropometric measurements
Description
Measurement of BMI Z-score
Time Frame
18 days
Title
Appetite
Description
appetite evaluation by visual analog scale before each meal
Time Frame
18 days
Title
Hunger
Description
hunger evaluation by visual analog scale before each meal
Time Frame
18 days
Title
Fasting IL6-8 levels
Time Frame
18 days
Title
Fasting adiponectin
Time Frame
18 days
Title
Fasting resistin
Time Frame
18 days
Title
Fasting MCP1
Time Frame
18 days
Title
Fasting PostPrandial
Time Frame
18 days
Title
Fasting GLP1 (glucagon-like peptide-1)
Time Frame
18 days
Title
Fasting Hba1C
Time Frame
18 days
Title
Body mass index z score
Time Frame
18 days
Title
sleep duration
Time Frame
18 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia FRANCO, MD
Phone
04 27 85 60 52
Ext
+33
Email
patricia.franco@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sonia GALLETTI
Phone
04 27 85 77 39
Ext
+33
Email
sonia.galletti@chu-lyon.fr
Facility Information:
Facility Name
Service d'Exploration et pathologie du sommeil, Hôpital Femme Mère Enfant
City
Bron
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Franco, MD
Phone
04 27 85 60 52
Ext
+33
Email
patricia.franco@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Sonia GALLETTI
Phone
04 27 85 77 39
Ext
+33
Email
sonia.galletti@chu-lyon.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Metabolism Characteristics in the Children With Narcolepsy
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