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

Juvenile Idiopathic Arthritis Clinical Trial

— OSE-JIA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02977416
• Other study ID #: CHU-0295
• Secondary ID: 2016-A01262-49
• Status: Recruiting
• Phase: N/A
• First received: November 28, 2016
• Last updated: December 2, 2016
• Start date: November 2016
• Est. completion date: September 2020

Study information

• Verified date: December 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: September 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• Children with juvenile idiopathic arthritis

Exclusion Criteria:

• active infection

• BMI > 25

• Systemic corticosteroid within last 3 months

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

Other:
• anti-TNFa

Locations

Country	Name	City	State
France	CHU Clermon-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage variation of the maximal fat oxidative rate during an exercise between JIA and healthy children. Timing:		at day 1 (first test)	Yes
Secondary	Percentage variation of substrates oxidative crossing point during an exercise.		at day 1	Yes
Secondary	Description of the contribution of energy systems during supra-maximal physical exercise	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	at day 1 (first test)	Yes