Actively Recruiting

Age: 18Years +
All Genders
ID07536529

Investigation of the Role of Redox Status in Patients With Autoimmune Rheumatic Diseases on Disease Progression: An Epidemiological Study

Led by University of Thessaly · Updated on 2026-04-28

200

Participants Needed

1

Research Sites

22 weeks

Total Duration

On this page

Sponsors

U

University of Thessaly

Lead Sponsor

G

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

Autoimmune rheumatic diseases (ARDs) are chronic inflammatory conditions that include rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, myositis, Sjogren's syndrome, and systemic scleroderma. These diseases cause joint damage and affect the body systemically, often alongside other health issues like cardiovascular disease and obesity. Researchers are studying the role of oxidative stress, a condition caused by an imbalance of free radicals and antioxidants in the blood, to better understand disease progression and improve monitoring methods for ARDs. This observational study will assess specific redox biomarkers in the blood of patients with ARDs at three time points: Day 1, Day 180, and Day 360. These biomarkers include reduced glutathione, catalase enzyme activity, total antioxidant capacity, and protein carbonyl concentration. In addition, inflammation markers like C-reactive protein and erythrocyte sedimentation rate will be measured. The study also collects data on physical activity, health status, quality of life, fatigue, sleep quality, nutritional habits, and medication history to explore their relationship with disease progression. Participants will provide blood samples and complete questionnaires at the three scheduled visits over one year. The study will evaluate changes in biomarker levels and clinical measures of disease severity, such as DAS28, PASI, and SLEDAI scores. This comprehensive assessment aims to determine whether redox biomarkers can serve as useful tools for tracking ARD progression. The study is sponsored by the University of Thessaly and plans to conclude by October 2026.

CONDITIONS

Brief Title

Oxidative Stress in Autoimmune Rheumatic Diseases

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients over 18 years old with a primary diagnosis of rheumatoid arthritis using ACR criteria
  • Adult patients over 18 years old with a primary diagnosis of psoriatic arthritis using CASPAR criteria
  • Adult patients over 18 years old with a primary diagnosis of ankylosing spondyloarthritis using ASAS criteria
  • Adult patients over 18 years old of any gender
  • Adult patients over 18 years old of any ethnicity
  • Adult patients over 18 years old with any comorbidities
  • Adult patients over 18 years old with any socioeconomic background
  • Adult patients over 18 years old with any disease status
  • Adult patients over 18 years old with any disease duration
  • Adult patients over 18 years old under any treatment scheme including non-steroidal anti-inflammatory drugs, steroids, and disease-modifying anti-rheumatic drugs including biologics
Not Eligible

You will not qualify if you...

  • Adult patients over 18 years old with a concurrent infectious disease
  • Adult patients over 18 years old who are pregnant
  • Patients under 18 years old

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Approximately 12 months

Participants have their blood redox status and various health parameters measured at multiple time points to observe disease progression.

3 visits (in-person) on Days 1, 180, and 360

Trial Site Locations

Total: 1 location

1

General University Hospital of Larissa. Greece

Larissa, Thessaly, Greece

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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Published Research Related To This Trial

Impact of Nutrition and Physical Activity Interventions Provided by Nutrition and Exercise Practitioners for the Adult General Population: A Systematic Review and Meta-Analysis.

Erin Nitschke, Kimberly Gottesman, Peggy Hamlett...

https://pubmed.ncbi.nlm.nih.gov/35565696