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Oxidation Rates of the Different Substrates During Exercise in Children and Adolescents With Juvenile Idiopathic Arthritis. Case-control Study and Cases Treated / Cases Not Treated With Anti-TNFα (OSE-JIA)

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ClinicalTrials.gov Identifier: NCT02977416
Recruitment Status : Recruiting
First Posted : November 30, 2016
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Tracking Information
First Submitted Date  ICMJE November 28, 2016
First Posted Date  ICMJE November 30, 2016
Last Update Posted Date December 5, 2016
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2016)
Percentage variation of the maximal fat oxidative rate during an exercise between JIA and healthy children. Timing: [ Time Frame: at day 1 (first test) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02977416 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2016)
  • Percentage variation of substrates oxidative crossing point during an exercise. [ Time Frame: at day 1 ]
  • Description of the contribution of energy systems during supra-maximal physical exercise [ Time Frame: at day 1 (first test) ]
    Description of the contribution of energy systems during supra-maximal physical exercise in patients with JIA according to JIA subtype, treatments, age, pubertal status, disease status
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxidation Rates of the Different Substrates During Exercise in Children and Adolescents With Juvenile Idiopathic Arthritis. Case-control Study and Cases Treated / Cases Not Treated With Anti-TNFα
Official Title  ICMJE Oxidation Rates of the Different Substrates During Exercise in Children and Adolescents With Juvenile Idiopathic Arthritis. Case-control Study and Cases Treated / Cases Not Treated With Anti-TNFα
Brief Summary

During exercise, energy comes mainly from carbohydrates and lipids. The relative contribution of lipids and glucose as energy substrates to exercise depends on the parameters of the exercise (duration, intensity and level of training) and the physiological conditions of the subject.

Inflammatory diseases such as juvenile idiopathic arthritis (JIA) are treated, for the most severe forms, by biotherapies. These treatments target certain pro-inflammatory cytokines including TNFα. In adults with rheumatoid arthritis several studies have shown that treatment with anti-TNFα increases insulin sensitivity. There is no data on the oxidation of energy substrates during exercise in children and adolescents with AJI, nor on the impact of anti-TNFα treatments on the oxidation of energetic substrates in children.

Investigators hypothesize that, compared to healthy children, children with JIA should exhibit altered oxidation of energy substrates at rest and submaximal physical exercise due to physical deconditioning and inflammation. In addition, those treated with anti-TNFα should have an oxidation profile of energy substrates at exercise different from that of patients not treated with anti-TNFα. Investigators also hypothesize that anti-TNFα treatments modify the contribution of energy chains (aerobic, anaerobic and anaerobic alactic) during the exercise.

Detailed Description

Annual evaluation by Lipoxmax test and Wingate anaerobic test (WAnT) during 3 years or until the transition from pediatric to adult care.

For healthy volunteer, only one lipaxmax and Wingate test.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Juvenile Idiopathic Arthritis
Intervention  ICMJE Other: anti-TNFα
Study Arms  ICMJE
  • Experimental: patients treated withTNF blockade
    22 patients treated with TNF blockade
    Intervention: Other: anti-TNFα
  • Experimental: patients without TNF blockade
    22 patients without TNF blockade
    Intervention: Other: anti-TNFα
  • Experimental: healthy subjects
    22 matched healthy subjects by pubertal stage and sex
    Intervention: Other: anti-TNFα
Publications * Rochette E, Bourdier P, Pereira B, Doré E, Birat A, Ratel S, Echaubard S, Duché P, Merlin E. TNF blockade contributes to restore lipid oxidation during exercise in children with juvenile idiopathic arthritis. Pediatr Rheumatol Online J. 2019 Jul 22;17(1):47. doi: 10.1186/s12969-019-0354-1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 29, 2016)
66
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children with juvenile idiopathic arthritis

Exclusion Criteria:

  • active infection
  • BMI > 25
  • Systemic corticosteroid within last 3 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02977416
Other Study ID Numbers  ICMJE CHU-0295
2016-A01262-49 ( Other Identifier: 2016-A01262-49 )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Clermont-Ferrand
Study Sponsor  ICMJE University Hospital, Clermont-Ferrand
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Etienne MERLIN University Hospital, Clermont-Ferrand
PRS Account University Hospital, Clermont-Ferrand
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP