Clinical Trial: Metabolism Characteristics in the Children With Narcolepsy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 ?


Detailed Summary:
Sponsor: Hospices Civils de Lyon

Current Primary Outcome: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Hospices Civils de Lyon

Dates:
Date Received: May 3, 2016
Date Started: December 2013
Date Completion: January 2017
Last Updated: June 14, 2016
Last Verified: May 2016