Oxidative Stress in Autoimmune Rheumatic Diseases

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Thessaly

About this trial

Rheumatic diseases constitute a group of non-communicable diseases characterized by chronic inflammation. The most common autoimmune rheumatic diseases (ARDs) are rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, myositis, Sjogren's syndrome and systemic scleroderma. These autoimmune disorders lead to joint destruction and adversely influence the human body systemically. One of their characteristics is comorbidity, since patients usually suffer also from other pathologies such as cardiovascular diseases and obesity. In addition, their treatment requires a combination of both biological and conventional pharmaceutical interventions as well as other parameters such as physical activity programs, nutrition, and the use of smart electronic devices. Therefore, the ARDs burden health systems worldwide. Apart from the physiological manifestations of ARDs, specific changes are observed at the cellular and molecular level. A common biochemical/molecular symptom of these diseases is oxidative stress. This condition leads to the disturbance of blood and tissue redox status due to the excessive production of free radicals. Given that free radicals are highly reactive moieties with strong oxidative capacity against biomolecules (i.e., proteins, lipids, DNA), they compromise the efficacy of the intrinsic antioxidant mechanisms and, finally, induce the disruption of redox homeostasis. However, there is no sufficient data linking the levels of redox status of patients with the progression of ARDs over time. Indeed, the onset and symptoms of ARDs are intertwined with the disruption of the patient redox homeostasis and the induction of oxidative stress. Concurrently, the absence of a completely effective pharmaceutical treatment emerges the need for the adoption of novel biomarkers for monitoring the severity of the symptoms and the evolution of ARDs in general. To that end, this study aims at first to investigate the blood redox status of patients with ARDs. Thus, specific redox biomarkers will be evaluated in the blood of patients in three time points (i.e., at Days 1, 180 and 360), and they will be associated with the clinical manifestations of their diseases. The ultimate goal is to clarify whether these biomarkers could putatively exert clinical significance, namely whether they could constitute an additional tool for the monitoring of the progression of these diseases in clinical practice.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (>18 years old), with a primary diagnosis of rheumatoid arthritis using the criteria of American College of Rheumatology (ACR)

Adult patients (>18 years old), with a primary diagnosis of psoriatic arthritis using the ClASsification criteria for Psoriatic Arthritis (CASPAR)

Adult patients (>18 years old), with a primary diagnosis of alkylosing spondyloarthritis using the criteria of Assessment of SpondyloArthritis international Society (ASAS) group

Adult patients (>18 years old) irrespective of gender

Disqualifiers

Adult patients (>18 years old) with concurrent infectious disease

Adult patients (>18 years old) in pregnancy

Patients under 18 years of age

Trial population

The study population comprises patients of the General University Hospital of Larissa

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 5 trial groups
Group A: Patients with rheumatoid arthritis
Group B: Patients with psoriatic arthritis
Group C: Patients with ankylosing spondylitis
Group D: Patients with systemic lupus erythematosus
Group E: Patients with scleroderma

Trial outcomes

Primary outcomes

1

Concentration of blood reduced glutathione (GSH)

The concentration of reduced form of glutathione (GSH) as a crucial intrinsic antioxidant metabolite will be measured spectrophotometrically in erythrocytes.

Time frame
GSH concentration will compared between Day 1 and Days 180 and 360

Secondary outcomes

1

Concentration of protein carbonyls in blood

The concentration of protein carbonyls, as a biomarker of protein oxidation, will be evaluated spectrophotometrically in plasma.

Time frame
Protein carbonyl concentration will compared between Day 1 and Days 180 and 360
2

Total antioxidant capacity (TAC) of blood

TAC is a crude biomarker of antioxidant capacity of blood

Time frame
TAC will be compared between Day 1 and Days 180 and 360
3

Activity of erythrocyte catalase

Catalase is a primary antioxidant enzyme

Time frame
Catalase activity will be compared between Day 1 and Days 180 and 360
4

Concentration of C-reactive protein (CRP) in blood

CRP is an established biomarker of acute inflammation

Time frame
CRP conentration will be compared between Day 1 and Days 180 and 360

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Thessaly

Lead sponsor

George Metsios, Professor, Department of Nutrition and Dietetics, University of Thessaly, Greece

Collaborator

General University Hospital of Larissa

Collaborator

Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece

Collaborator

Dimitrios P. Bogdanos, Professor, Department of Rheumatology and Clinical Immunology, Larissa University Hospital

Collaborator