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Effect Of The System In The Enriched Fat Metabolism Of The Child Reached Mitochondrial Cytopathy (MITOX)

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ClinicalTrials.gov Identifier: NCT02385565
Recruitment Status : Completed
First Posted : March 11, 2015
Last Update Posted : March 11, 2015
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:

The aim of the present study is to compare Resting Energy Expenditure (REE) between normal fat diet (NFD) as a control vs high fat diet (HFD) as a treatment in Mitochondrial cytopathies disorders ( MID's ) patients. Secondary objectives is to compare diet induced thermogenesis (DIT) and body composition between NFD vs HFD.

This study is a randomized cross-over study. Normal fat diet (ie 10 % proteins, 45 % lipids, 45 % carbohydrates) is the imposed diet at baseline, high fat diet (ie 10 % proteins, 30 % lipids, 60 % carbohydrates is used according to the cross-over design trial. Main evaluation criteria is REE and second evaluation criteria is DIT both measured by indirect calorimetry ). 36 included MID subjects will be included in this study. Main evaluation criteria and second evaluation criteria will be measured at baseline, 1 month, 2 month and 3 month.


Condition or disease Intervention/treatment Phase
Mitochondrial Cytopathies Disorders Other: high fat diet Other: normal fat diet Not Applicable

Detailed Description:
REE and DIT are measured by indirect calorimetry . The device used is a using an open-circuit ventilated hood system (QUARK RMR®, Cosmed, Pavona; Italy). The respiration quo- tient (RQ) and flow settings are calibrated by reference to alcohol combustion every six months. Before each test, the calorimeter is calibrated with a reference gas mixture (5% CO2, 95% O2 v/v). Expired carbon di- oxide (VCO2) and inspired oxygen (VO2) -flows are recorded, as well as the RQ. EE is calculated every minute from oxygen consumption (VO2 in ml/min) and carbon dioxide production (VCO2 in ml/min) using the Weir formula without protein correction. DIT is measured during 6 hours after a calibrated breakfast (normal fat diet or high fat diet according to the cross-over design) as 30% of theoric energy intake.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect Of The System In The Enriched Fat Metabolism Of The Child Reached Mitochondrial Cytopathy
Study Start Date : February 2004
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2009


Arm Intervention/treatment
Experimental: high fat diet
10 % proteins, 30 % lipids, 60 % carbohydrates
Other: high fat diet
high fat diet as 10 % proteins, 30 % lipids, 60 % carbohydrates

Placebo Comparator: Normal fat diet
10 % proteins, 45 % lipids, 45 % carbohydrates
Other: normal fat diet
high fat diet as 10 % proteins, 45 % lipids,45 % carbohydrates




Primary Outcome Measures :
  1. resting energy expenditure [ Time Frame: up to 3 months ]
    resting energy expenditure measured by indirect calorimetry


Secondary Outcome Measures :
  1. diet induced thermogenesis [ Time Frame: baseline, 1 month, 2 months, 3 months ]
    diet induced thermogenesis measured by indirect calorimetry

  2. body composition [ Time Frame: baseline, 1 month, 2 months, 3 months ]
    body composition by DEXA



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Ages Eligible for Study:   5 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 5 to 21 years-old children,

    • Children with a proven mitochondrial cytopathy documented on biopsies by histology, histoenzymology, ultrastructure and enzyme assay and/or on body fluids by laboratory markers including lactacidemia, metabolic acidosis, increased CSF lactate, lactate/pyruvate and beta-hydroxybutyrate/acetoacetate ratios, paradoxical postprandial ketonemia, alaninemia, citrullinemia, plasma acylcarnitines.
    • Children on the usual diet (30% lipids, 60% glucides and 10% proteins) for at least 1 month.
    • Informed consent of the 2 parents and from the child when in age to express a consent.
    • Child with a social security cover.

Exclusion Criteria:

  • Acute infection (fever > 38.5°C for more than 6h) within 7 days prior to the study.
  • Disability for understanding and following the protocol
  • Rejection of the study by the patient or failure to comply to the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02385565


Locations
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France
Centre d'Investigation Clinique
Lille, France, 59037
Centre d'Investigation Clinique
Paris, France, 75000
Sponsors and Collaborators
University Hospital, Lille
Ministry of Health, France
Investigators
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Principal Investigator: Dries DOBBELAERE, MD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02385565     History of Changes
Other Study ID Numbers: 2004/0401
2004/0138 ( Other Identifier: DGS )
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
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Retinitis Pigmentosa
Kearns-Sayre Syndrome
Ophthalmoplegia, Chronic Progressive External
Mitochondrial Myopathies
Muscular Diseases
Musculoskeletal Diseases
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Paralysis
Neurologic Manifestations
Neuromuscular Diseases
Eye Diseases
Retinal Dystrophies
Retinal Degeneration
Retinal Diseases
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Mitochondrial Diseases
Metabolic Diseases
Signs and Symptoms