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
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|
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|
|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|
Experimental: patients treated withTNF blockade
22 patients treated with TNF blockade
Experimental: patients without TNF blockade
22 patients without TNF blockade
Experimental: healthy subjects
22 matched healthy subjects by pubertal stage and sex
- Percentage variation of the maximal fat oxidative rate during an exercise between JIA and healthy children. Timing: [ Time Frame: at day 1 (first test) ]
- 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
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
|Contact: Patrick LACARIN||04 73 75 11 firstname.lastname@example.org|
|Clermont-Ferrand, France, 63003|
|Contact: Patrick LACARIN 0473751195 email@example.com|
|Principal Investigator: Etienne MERLIN|
|Principal Investigator:||Etienne MERLIN||University Hospital, Clermont-Ferrand|