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Trial record 3 of 32 for:    Recruiting, Not yet recruiting, Available Studies | "Arthritis, Juvenile Rheumatoid"

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

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.


Condition or disease Intervention/treatment Phase
Juvenile Idiopathic Arthritis Other: anti-TNFα Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : November 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: patients treated withTNF blockade
22 patients treated with TNF blockade
Other: anti-TNFα
Experimental: patients without TNF blockade
22 patients without TNF blockade
Other: anti-TNFα
Experimental: healthy subjects
22 matched healthy subjects by pubertal stage and sex
Other: anti-TNFα



Primary Outcome Measures :
  1. Percentage variation of the maximal fat oxidative rate during an exercise between JIA and healthy children. Timing: [ Time Frame: at day 1 (first test) ]

Secondary Outcome Measures :
  1. Percentage variation of substrates oxidative crossing point during an exercise. [ Time Frame: at day 1 ]
  2. 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



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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children with juvenile idiopathic arthritis

Exclusion Criteria:

  • active infection
  • BMI > 25
  • Systemic corticosteroid within last 3 months

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): NCT02977416


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermon-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    0473751195    placarin@chu-clermontferrand.fr   
Principal Investigator: Etienne MERLIN         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Etienne MERLIN University Hospital, Clermont-Ferrand

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02977416     History of Changes
Other Study ID Numbers: CHU-0295
2016-A01262-49 ( Other Identifier: 2016-A01262-49 )
First Posted: November 30, 2016    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: December 2016

Keywords provided by University Hospital, Clermont-Ferrand:
Juvenile idiopathic arthritis
fat oxidation
exercise

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases