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

Primary Purpose

Active Rheumatoid Arthritis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Energy metabolism of patients suffering from RA
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Active Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Sites / Locations

  • CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

16 patients with active RA

8 Healthy volunteers (control group)

Arm Description

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).

Outcomes

Primary Outcome Measures

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.
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.
Nutritionist assessment of nutritional intake
Nutritionist assessment of nutritional intake during the 2 days preceding energy expenditure measurement.
Previously-scheduled tests for the RCVRIC protocol

Secondary Outcome Measures

Indirect assessment of energy expenditure via measurement of physical activity using calibrated actimetry (Armband)
Indirect assessment of energy expenditure via measurement of physical activity using calibrated actimetry (Armband) at home in normal living conditions over 4 days.
Nutritionist evaluation of nutritional intake over 2 days
Previously-scheduled tests for the RCVRIC study protocol (M6):
DXA, pQCT, physical strength and performance, physical activity and nutrition questionnaires, cardiovascular risk, serum and urine bank research.

Full Information

First Posted
November 15, 2017
Last Updated
November 20, 2017
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Centre de Recherche en Nutrition Humaine d'Auvergne
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1. Study Identification

Unique Protocol Identification Number
NCT03346590
Brief Title
Evolution of Total Energy Expenditure and Its Various Components in Active Rheumatoid Arthritis (RA)Treated With Anti-TNF Agents and Comparison With Healthy Subjects
Official Title
Evolution of Total Energy Expenditure and Its Various Components in Active Rheumatoid Arthritis (RA)Treated With Anti-TNF Agents and Comparison With Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 30, 2017 (Anticipated)
Primary Completion Date
October 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Centre de Recherche en Nutrition Humaine d'Auvergne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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'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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Active Rheumatoid Arthritis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
No masking
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
16 patients with active RA
Arm Type
Active Comparator
Arm Description
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.
Arm Title
8 Healthy volunteers (control group)
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Energy metabolism of patients suffering from RA
Intervention Description
Energy metabolism of patients suffering from RA
Primary Outcome Measure Information:
Title
Continuous measurement of energy expenditure and cardiac rhythm in calorimetric chamber
Description
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.
Time Frame
for 36 hours
Title
Indirect assessment of energy expenditure
Description
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.
Time Frame
for 4 days
Title
Nutritionist assessment of nutritional intake
Description
Nutritionist assessment of nutritional intake during the 2 days preceding energy expenditure measurement.
Time Frame
during the 2 days preceding energy expenditure measurement.
Title
Previously-scheduled tests for the RCVRIC protocol
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
Indirect assessment of energy expenditure via measurement of physical activity using calibrated actimetry (Armband)
Description
Indirect assessment of energy expenditure via measurement of physical activity using calibrated actimetry (Armband) at home in normal living conditions over 4 days.
Time Frame
at 6 months
Title
Nutritionist evaluation of nutritional intake over 2 days
Time Frame
at 6 months
Title
Previously-scheduled tests for the RCVRIC study protocol (M6):
Description
DXA, pQCT, physical strength and performance, physical activity and nutrition questionnaires, cardiovascular risk, serum and urine bank research.
Time Frame
at 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
0473751195
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne TOURNADRE
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
0473751195
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Anne TOURNADRE
First Name & Middle Initial & Last Name & Degree
Ruddy RICHARD
First Name & Middle Initial & Last Name & Degree
Christophe MONTAURIER
First Name & Middle Initial & Last Name & Degree
Martin SOUBRIER
First Name & Middle Initial & Last Name & Degree
Yves BOIRIE

12. IPD Sharing Statement

Learn more about this trial

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

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