- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04927546
Acute Response to Exercise in Patients With Rheumatoid Arthritis
23. august 2021 opdateret af: Bruno Gualano, University of Sao Paulo
Impact of Interleukin-6 Receptor Blockade on Acute Response to Exercise on Insulin Sensitivity and Muscle Glucose Uptake in Patients With Rheumatoid Arthritis
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Sao Paulo, Brasilien, 05508-030
- Rekruttering
- Univsersity of Sao Paulo
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Kontakt:
- Bruno Gualano, PhD
- Telefonnummer: 551126618022
- E-mail: gualano@usp.br
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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;
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: IL-6 blockade
RA patients under pharmacological treatment with interleukin-6 blockade.
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Thirty minutes of aerobic exercise in a treadmill.
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Eksperimentel: Anti-TNF-alpha
RA patients under pharmacological treatment with anti-TNF-alpha.
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Thirty minutes of aerobic exercise in a treadmill.
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Eksperimentel: Healthy controls
Healthy participants.
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Thirty minutes of aerobic exercise in a treadmill.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Insulin sensitivity
Tidsramme: 1 hour post-exercise
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Acute effect of exercise on insulin sensitivity assessed by the hyperinsulinemic euglycemic clamp.
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1 hour post-exercise
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Insulin sensitivity-related molecular pathway (Western Blotting)
Tidsramme: Baseline and 4 hours post-exercise
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Insulin sensitivity-related molecular pathway will be assessed by Western Blotting.
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Baseline and 4 hours post-exercise
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Insulin sensitivity-related molecular pathway (RT-PCR)
Tidsramme: Baseline and 4 hours post-exercise
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Insulin sensitivity-related molecular pathway will be assessed by Real-Time Polymerase Chain Reaction (RT-PCR).
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Baseline and 4 hours post-exercise
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Skeletal muscle glucose uptake
Tidsramme: 3 hours post-exercise
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Positron emission tomography-magnetic resonance imaging (PET/MRI) will be performed to quantify skeletal muscle glucose uptake.
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3 hours post-exercise
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. august 2021
Primær færdiggørelse (Forventet)
1. juli 2023
Studieafslutning (Forventet)
1. juli 2023
Datoer for studieregistrering
Først indsendt
3. juni 2021
Først indsendt, der opfyldte QC-kriterier
8. juni 2021
Først opslået (Faktiske)
16. juni 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. august 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. august 2021
Sidst verificeret
1. august 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IL-6 blockade and exercise
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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