NCT02977416

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

December 5, 2016

Status Verified

December 1, 2016

Enrollment Period

3.5 years

First QC Date

November 28, 2016

Last Update Submit

December 2, 2016

Conditions

Juvenile Idiopathic Arthritis

Keywords

Juvenile idiopathic arthritisfat oxidationexercise

Outcome Measures

Primary Outcomes (1)

  • Percentage variation of the maximal fat oxidative rate during an exercise between JIA and healthy children. Timing:

    at day 1 (first test)

Secondary Outcomes (2)

  • Percentage variation of substrates oxidative crossing point during an exercise.

    at day 1

  • Description of the contribution of energy systems during supra-maximal physical exercise

    at day 1 (first test)

Study Arms (3)

patients treated withTNF blockade

EXPERIMENTAL

22 patients treated with TNF blockade

Other: anti-TNFα

patients without TNF blockade

EXPERIMENTAL

22 patients without TNF blockade

Other: anti-TNFα

healthy subjects

EXPERIMENTAL

22 matched healthy subjects by pubertal stage and sex

Other: anti-TNFα

Interventions

anti-TNFαOTHER
healthy subjectspatients treated withTNF blockadepatients without TNF blockade

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children with juvenile idiopathic arthritis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermon-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (1)

  • Rochette E, Bourdier P, Pereira B, Dore E, Birat A, Ratel S, Echaubard S, Duche P, Merlin E. TNF blockade contributes to restore lipid oxidation during exercise in children with juvenile idiopathic arthritis. Pediatr Rheumatol Online J. 2019 Jul 22;17(1):47. doi: 10.1186/s12969-019-0354-1.

    PMID: 31331342DERIVED

MeSH Terms

Conditions

Arthritis, JuvenileMotor Activity

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Officials

  • Etienne MERLIN

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2016

First Posted

November 30, 2016

Study Start

November 1, 2016

Primary Completion

May 1, 2020

Study Completion

September 1, 2020

Last Updated

December 5, 2016

Record last verified: 2016-12

Locations

FR(1)