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Adversity and Its Association With the Development and Expression of Rheumatic Diseases

Adversity and Its Association With the Development and Expression of Rheumatic Diseases

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06386380
Acronym
RD
Enrollment
110
Registered
2024-04-26
Start date
2024-06-01
Completion date
2026-02-01
Last updated
2024-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RhA - Rheumatoid Arthritis

Keywords

Adversity, Rheumatic diseases

Brief summary

Epidemiological evidence shows that adverse experiences, particularly, but not exclusively in childhood, are predictors of poor long-term health outcomes and certain social domains. In the field of rheumatic diseases, traumatic events, not only in childhood, have been associated with hospitalization, chronic pain, inflammation, worse outcomes, severity of the disease, and mortality. Some mechanisms proposed to explain the association between the experience of adversity and the development of chronic diseases include an impact on the physiology of immune system cells, gene expression due to DNA modification, and cellular senescence. With this background, the investigators wonder if, for patients with rheumatoid arthritis, the presence of adversity understood as a history of violence in childhood and abuse due to suffering from rheumatoid arthritis is associated with markers of cellular senescence and with the severity of illness.

Detailed description

To answer this question, the investigators proposed conducting a study on outpatients diagnosed with rheumatoid arthritis treated at the INCMNSZ. Patients who agree to participate will be asked to answer some questionnaires to report their perception of child abuse and abuse derived from suffering from rheumatoid arthritis, disease activity, disability, quality of life, anxiety, stress, depression, and resilience. Additionally, a peripheral blood sample will be taken to evaluate cellular senescence through CD27, CD28, and CD57 expression, the relative expression of the p16INK4a gene in CD3+ lymphocytes, HLA-DR, CD25, and CD69, and telomere length. Finally, the expression of the severity of the disease will be determined.

Interventions

In 2012, Giraldo-Rodríguez developed and validated the Geriatric Mistreatment Scale (GAS); translation, cultural adaptation, and validation were performed prior to its application.

RAPID- 3 measures: function, pain, and patient global status estimate. Each of the three individual measures is scored 0 to 10, for a total of 30

The HAQ is based on five patient-centered dimensions: disability, pain, medication effects, costs of care, and mortality.

WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health, psychological health, social relationships, and environmental health; it also contains QOL and general health items

DASS-21 is a set of three self-report scales designed to measure the emotional states of depression, anxiety, and stress. Each of the three DASS-21 scales contains seven items, divided into subscales with similar content.

The Brief Resilient Coping Scale is a 4-item measure designed to capture tendencies to cope with stress in a highly adaptive manner.

GENETICExpression of CDKN2A /p16INK4a

CDKN2A/p16INK4a expression will be measured using the Taqman qPCR assay (TaqMan Universal Master Mix II, with UNG, Applied Biosystems, Foster City, USA) according to the manufacturer's specifications.

OTHERImmunophenotype of leukocyte subpopulations

CD4+ and CD8+ subpopulations will be analyzed. Blood samples will be analyzed by 8-color flow cytometry (Becton Dickinson Canto II cytometer) using fluorescently labeled antibodies from Biolegend Inc. (San Diego, USA).

The rLTL will be estimated by quantitative monochromatic multiplex PCR (MM-qPCR). Integrated DNA Technologies, Inc. (IDT, Coralville, IA, USA) will synthesize the primers used for telomere measurements.

OTHERCellular senescence

Expression of co-stimulatory molecules and surface receptors CD27- and CD28-

Sponsors

National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Patients with a rheumatoid arthritis diagnosis, according to their primary rheumatologist who agrees to participate

Exclusion criteria

* Patients with a not confirmed rheumatoid arthritis diagnosis

Design outcomes

Primary

MeasureTime frameDescription
Adversity and senescence in patients with rheumatoid arthritisAt inclusion (baseline moment) (cross-sectional study)]To evaluate whether the presence of adversity (history of abuse in childhood and/or abuse associated with RD) is associated with markers of senescence in patients with rheumatoid arthritis.

Secondary

MeasureTime frameDescription
Eexpression of the p16INK4a gene in CD3+At inclusion (baseline moment) (cross-sectional study)]Compare the relative expression of the p16INK4a gene in CD3+ lymphocytes between rheumatoid arthritis patients with and without adversity.
Telomere lengthAt inclusion (baseline moment) (cross-sectional study)]Compare telomere length between RA patients with and without adversity.

Contacts

Primary ContactVirginia MD Pascual-Ramos, MD
virtichu@gmail.com525555734111
Backup ContactIrazu MD Contreras-Yáñez, MD
virtichu@gmail.com525555734111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026