Status:
UNKNOWN
Evolution of Total Energy Expenditure and Its Various Components in Active Rheumatoid Arthritis (RA)Treated With Anti-TNF Agents and Comparison With Healthy Subjects
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
Centre de Recherche en Nutrition Humaine d'Auvergne
Conditions:
Active Rheumatoid Arthritis
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Chronic inflammation in rheumatoid arthritis is associated with adiposity, sarcopenia, cachexia, reduced activity due to functional impairment, and anti-inflammatory drugs. Patients frequently gain we...
Detailed Description
Few studies have been focused on the combined evolution of body composition, energy expenditure, physical activity, muscle performance, and nutritional intake in patients taking anti-TNFs. This study...
Eligibility Criteria
Inclusion
- RA patients 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.
- \- 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
- Refusal to sign consent form.
- 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.
Key Trial Info
Start Date :
November 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03346590
Start Date
November 30 2017
End Date
December 31 2019
Last Update
November 21 2017
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003