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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


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
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