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

Not Applicable

• Conditions: Juvenile Idiopathic Arthritis
• Interventions: Other: anti-TNFα

• Registration Number: NCT02977416
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-28
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-11-30
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-02
• Last Update Posted: 2016-12-05
• Primary Completion: 2020-05
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Children with juvenile idiopathic arthritis

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
healthy subjects	anti-TNFα	22 matched healthy subjects by pubertal stage and sex
patients without TNF blockade	anti-TNFα	22 patients without TNF blockade
patients treated withTNF blockade	anti-TNFα	22 patients treated with TNF blockade

Primary Outcome Measures

Name	Time	Method
Percentage variation of the maximal fat oxidative rate during an exercise between JIA and healthy children. Timing:	at day 1 (first test)

Secondary Outcome Measures

Name	Time	Method
Description of the contribution of energy systems during supra-maximal physical exercise	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
Percentage variation of substrates oxidative crossing point during an exercise.	at day 1

Trial Locations

Locations (1)

CHU Clermon-Ferrand; 🇫🇷 Clermont-Ferrand, France