Juvenile Idiopathic ArthritisOSE-JIANCT02977416
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
A study testing anti-TNFα in people with Juvenile Idiopathic Arthritis, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- anti-TNFα
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2016to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children with juvenile idiopathic arthritis
Who cannot join
- active infection
- BMI > 25
- Systemic corticosteroid within last 3 months
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermon-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 0473751195, placarin@chu-clermontferrand.fr
Etienne MERLIN
About this study
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.
Read the 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.
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- anti-TNFα
- Keywords
- Juvenile idiopathic arthritis, fat oxidation, exercise
- Medical subject headings
- Arthritis, Juvenile, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-TNFαOther
| Study group | Role | What they receive |
|---|---|---|
| patients treated withTNF blockade | Experimental | 22 patients treated with TNF blockade Receives: Other: anti-TNFα |
| patients without TNF blockade | Experimental | 22 patients without TNF blockade Receives: Other: anti-TNFα |
| healthy subjects | Experimental | 22 matched healthy subjects by pubertal stage and sex Receives: Other: anti-TNFα |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage variation of the maximal fat oxidative rate during an exercise between JIA and healthy children. Timing:
Measured: at day 1 (first test)
Secondary outcomes (2)
Percentage variation of substrates oxidative crossing point during an exercise.
Measured: at day 1
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
Measured: at day 1 (first test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMay 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne MERLIN, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977416
- Sponsor's protocol ID
- CHU-0295
- Other IDs
- 2016-A01262-49
- Acronym
- OSE-JIA
- Status last verified
- Dec 2016
- First submitted
- 28 Nov 2016
- Last updated
- 5 Dec 2016
- Results posted
- No
Publications
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.
PubMed 31331342
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02977416
- Acronym / sponsor ID
- OSE-JIA / CHU-0295
- Conditions
- Juvenile Idiopathic Arthritis
- Keywords
- Juvenile idiopathic arthritis, fat oxidation, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- May 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 30 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients treated withTNF blockade | Experimental | Other: anti-TNFα22 patients treated with TNF blockade |
| patients without TNF blockade | Experimental | Other: anti-TNFα22 patients without TNF blockade |
| healthy subjects | Experimental | Other: anti-TNFα22 matched healthy subjects by pubertal stage and sex |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children with juvenile idiopathic arthritis
Key exclusion criteria (3 listed)
- active infection
- BMI > 25
- Systemic corticosteroid within last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-TNFα | Other | healthy subjects, patients treated withTNF blockade, patients without TNF blockade |
Primary outcome
Percentage variation of the maximal fat oxidative rate during an exercise between JIA and healthy children. Timing:
Time frame: at day 1 (first test)
2 secondary outcomes
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
- Derived from this study: PubMed 31331342Rochette 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etienne MERLIN principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anti-TNFα in people with Juvenile Idiopathic Arthritis, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage variation of the maximal fat oxidative rate during an exercise between JIA and healthy children. Timing: (time frame: at day 1 (first test)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02977416, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2016.