Clinical trial NCT04927546: Acute Response to Exercise in Patients With Rheumatoid Arthritis
Official title: Impact of Interleukin-6 Receptor Blockade on Acute Response to Exercise on Insulin Sensitivity and Muscle Glucose Uptake in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RA patients will be divided into 2 groups, according to the pharmacological treatment (tocilizumab or anti-TNF). A third group will be composed by healthy controls. The acute responses of insulin sensitivity after an acute session of exercise will be assessed by the hyperinsulinemic euglycemic clamp, and the molecular pathways will be assessed by muscle biopsy and gene and protein expression analysis. Positron emission tomography-magnetic resonance imaging (PET/MRI) will be performed to quantify skeletal muscle glucose uptake.
Primary purpose: TREATMENT

Brief summary: Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects the joints, causing pain, edema, physical disability and poor quality of life. In addition, RA patients are at increased risk of developing cardiovascular disease (CVD) and premature death. The most effective pharmacological treatment is the use of biological agents that inhibit the action of specific substances, such as interleukin 6 (IL-6) and tumor necrosis factors (TNF). Physical exercise is considered a first-line non-pharmacological treatment in RA, improving inflammatory and metabolic profile, functional capacity, fatigue and preventing the onset of CVD. There is evidence that IL-6, when secreted as a result of exercise, brings several benefits. However, there is no study investigating the interaction between biological IL-6 blocking agents and exercise on metabolic responses, such as insulin sensitivity and glucose uptake, in patients with RA. To answer this question, adult women diagnosed with RA and healthy controls will be recruited for an acute session of exercise. RA patients will be divided into 2 groups, according to the pharmacological treatment (tocilizumab or anti-TNF). The acute responses of insulin sensitivity after an acute session of exercise will be assessed by the hyperinsulinemic euglycemic clamp, and the molecular pathways will be assessed by muscle biopsy and gene and protein expression analysis. Positron emission tomography-magnetic resonance imaging (PET/MRI) will be performed to quantify skeletal muscle glucose uptake.


Eligibility criteria: Inclusion Criteria:

* Adult women diagnosed with rheumatoid arthritis under pharmacological treatment, for at least 6 months, with a monoclonal antibody against the interleukin-6 receptor or TNF-alpha inhibitors;
* Stable dose of monoclonal antibody against the interleukin-6 receptor or TNF-alpha inhibitors in the previous 3 months;

Exclusion Criteria:

* Any physical limitation or disability that preclude exercise participation;
* Participation in a structured exercise program in the previous 12 months;

Primary outcomes:
measure: Insulin sensitivity
timeFrame: 1 hour post-exercise
Secondary outcomes:
measure: Insulin sensitivity-related molecular pathway (Western Blotting)
timeFrame: Baseline and 4 hours post-exercise
measure: Insulin sensitivity-related molecular pathway (RT-PCR)
timeFrame: Baseline and 4 hours post-exercise
measure: Skeletal muscle glucose uptake
timeFrame: 3 hours post-exercise
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Univsersity of Sao Paulo
Study officials:
References: