Evolution of Total Energy Expenditure and Its Various Components in Active Rheumatoid Arthritis (RA)Treated With Anti-TNF Agents and Comparison With Healthy Subjects

NCT03346590 | Unknown

• 2 other identifiers: CHU-3652017-A01654-49
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 weight when taking anti-tumor necrosis factor (TNF) medication, prompting questions about the underlying mechanism and long-term cardiovascular and metabolic tolerance associated with these drugs The primary objective of this study is to analyze the impact of anti-TNF treatment during the first year of administration on the energy metabolism of patients suffering from RA, assessed as an absolute value (before-after) and in comparison with a standard measured in healthy matched subjects.

Conditions

Active Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (4)

• Continuous measurement of energy expenditure and cardiac rhythm in calorimetric chamber

  Continuous measurement of energy expenditure and cardiac rhythm in calorimetric chamber for 36 hours: at rest, waking, during two physical activity sessions (treadmill walking at 4km/h for 30min), sleeping.

  for 36 hours

• Indirect assessment of energy expenditure

  Indirect assessment of energy expenditure by measuring physical activity using home actimetry(Armband) under normal living conditions for 4 days and in the calorimetric chamber for calibration.

  for 4 days

• Nutritionist assessment of nutritional intake

  Nutritionist assessment of nutritional intake during the 2 days preceding energy expenditure measurement.

  during the 2 days preceding energy expenditure measurement.

• Previously-scheduled tests for the RCVRIC protocol

  at day 1

Secondary Outcomes (3)

• Indirect assessment of energy expenditure via measurement of physical activity using calibrated actimetry (Armband)

  at 6 months

• Nutritionist evaluation of nutritional intake over 2 days

  at 6 months

• Previously-scheduled tests for the RCVRIC study protocol (M6):

  at 6 months

Study Arms (2)

16 patients with active RA

ACTIVE COMPARATOR

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.

Behavioral: Energy metabolism of patients suffering from RA

8 Healthy volunteers (control group)

SHAM COMPARATOR

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).

Behavioral: Energy metabolism of patients suffering from RA

Interventions

Energy metabolism of patients suffering from RA BEHAVIORAL

Energy metabolism of patients suffering from RA

16 patients with active RA; 8 Healthy volunteers (control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Centre de Recherche en Nutrition Humaine d'Auvergne: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Study Officials

• Anne TOURNADRE

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

0473751195; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 17, 2017
• Study Start: November 30, 2017
• Primary Completion: October 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 21, 2017

Record last verified: 2017-11

Locations

FR (1)