Evolution of Total Energy Expenditure and Its Various Components in Active Rheumatoid Arthritis (RA)Treated With Anti-TNF Agents and Comparison With Healthy Subjects
NCT ID: NCT03346590
Last Updated: 2017-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
24 participants
INTERVENTIONAL
2017-11-30
2019-12-31
Brief Summary
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Detailed Description
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This study's objective is to assess the impact of anti-TNF treatment during the first year of administration on the energy metabolism of RA patients, measuring variations in basal daily energy expenditure and per type of expenditure using indirect calorimetry with calorimetric chambers. Investigator also aim to define standardized values for RA patients compared to healthy matched controls and to be able to monitor the evolution of these different values during treatment compared to this standard.
This will be an exploratory study with a longitudinal follow-up of the cohort in patients treated in a market authorization context and involving a case/control study. Investigator judged the inclusion of healthy controls justified by the current lack of data comparing the different components of energy metabolism in active RA patients versus healthy subjects using calorimetric chamber measurement. The aim is to obtain reference values to situate RA-specific values in comparison before and after treatment. Investigator considered selecting controls from the RA patients unjustified given how essential it is to commence treatment in active RA cases (1 year with placebo not justifiable). A previously-treated inactive RA population with no inflammation would not be comparable to patients with active RA, and neither would a population with active RA treated with conventional treatment or a different biotherapy to anti-TNFs. Investigator also chose to perform a second assessment at 6 months without calorimetric chamber measurement but rather an indirect measurement using actimetry in order to limit costs and patients lost-to-follow-up due to treatment modification (failure or intolerance), all the while maintaining full assessment at 12 months. Scheduling the assessment at 12 months is justified by published studies' reports of delay before significant weight gain manifests, and enables us to maintain homogeneity as regards variations in physical activity and nutritional intake linked to seasonal changes.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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16 patients with active RA
Women over 18 years old with proven active (DAS28 \>3.2) RA, diagnosed based on ACR/EULAR 2010 criteria, receiving biological anti-TNF treatment for the first time.
Covered by social security. Capable of giving informed consent and acceding to the requirements of the study. For high-resolution echocardiography: no hypertension, diabetes or history of cardiovascular disorders.
Energy metabolism of patients suffering from RA
Energy metabolism of patients suffering from RA
8 Healthy volunteers (control group)
Healthy volunteers (control group) The healthy female controls will be enrolled from the Centre de Recherche en Nutrition Humaine (CRNH) list of volunteers and matched to the RA patients according to age ±5 years and BMI class (\<25; 25-30; \>30).
Energy metabolism of patients suffering from RA
Energy metabolism of patients suffering from RA
Interventions
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Energy metabolism of patients suffering from RA
Energy metabolism of patients suffering from RA
Eligibility Criteria
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Inclusion Criteria
Covered by social security. Capable of giving informed consent and acceding to the requirements of the study.
For high-resolution echocardiography: no hypertension, diabetes or history of cardiovascular disorders.
\- Healthy volunteers (control group) The healthy female controls will be enrolled from the Centre de Recherche en Nutrition Humaine (CRNH) list of volunteers and matched to the RA patients according to age ±5 years and BMI class (\<25; 25-30; \>30).
Exclusion Criteria
* Patients under guardianship or curatorship.
* Previous exposure to biological treatment in the course of their disease.
* Suffering from a condition potentially influencing energy metabolism: infection, cancer, diabetes, thyroid dysfunction, psychiatric disorder, current smoker, pregnancy.
* High physical activity level, based on short-form IPAQ questionnaire.
* Variations in weight exceeding 5% of body weight in the previous 6 months.
18 Years
FEMALE
Yes
Sponsors
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Centre de Recherche en Nutrition Humaine d'Auvergne
OTHER_GOV
University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Anne TOURNADRE
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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CHU Clermont-Ferrand
Clermont-Ferrand, , France
Countries
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Central Contacts
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Facility Contacts
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Patrick LACARIN
Role: primary
Other Identifiers
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2017-A01654-49
Identifier Type: OTHER
Identifier Source: secondary_id
CHU-365
Identifier Type: -
Identifier Source: org_study_id