Adipokines as Predictors of Foot Function, Pain, and Disability in Patients With Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT04036669|
Recruitment Status : Completed
First Posted : July 30, 2019
Last Update Posted : July 30, 2019
Significant increase in the levels of serum adiponectin, ADA, and hsCRP was reported in all RA patients compared to controls.
Compared to patients with early RA, the increase in these markers significantly correlated with disease activity (DAS-ESR), lower f-BMD, radiographic scoring, pain, FFI, and functional limitations in patients with established RA.
Adiponectin showed a negative correlation with serum levels of both ADA and hsCRP. By using ROC curve analysis, optimal cut-off values of adiponectin (28.8 µg/ml), ADA (27.3 IU/L), and hsCRP (1.6 mg/L) could be used to estimate early RA in 45 % of the patients. Similarly, using cut-off values of adiponectin (32.8 µg/ml), ADA (26.1 IU/L ml), and hsCRP (2.5 mg/L), established RA could be predicted in 55 % of patients with 98-99% accuracy.
|Condition or disease|
|Rheumatoid Arthritis Healthy Control|
|Study Type :||Observational|
|Actual Enrollment :||160 participants|
|Official Title:||Foot Bone Mineral Density and Inflammation in Rheumatoid Arthritis|
|Actual Study Start Date :||February 20, 2014|
|Actual Primary Completion Date :||April 30, 2015|
|Actual Study Completion Date :||May 30, 2015|
RA patients ( N=80; BMI= 26.4± 3.96 ) Eighty patients diagnosed with Rheumatoid arthritis according to American Rheumatology Association criteria and radiographic analysis for at least 10 years previously were randomly involved in this study
A healthy control group ( N=80; BMI=22.3± 1.85) eighty age and sex-matched healthy controls were included in the study following the assignment of informed consent.
- Estimation of Foot bone mineral density (f-BMD) [ Time Frame: 3 months ]Foot BMD for all RH patients was performed by Dual Energy X-ray Absorptiometry (DEXA) scan method by using a Lunar DPX densitometer originally used to measure bone mass of small animals and modified to suits the measurements of hand BMD. Foot measurements were applied according to previously reported method
- Foot Function Index [ Time Frame: 3 months ]Foot Function Index (FFI) is pre-validated questionnaire designed efficiently to measure the effects of foot pathologies such as Rheumatoid Arthritis (RA) on foot function in terms of pain, disability and activity restriction. The FFI has three subscales of measurements; pain, disability, and activity limitation with a total of 23 questions and total score of 10. For each patients, record the respective measurements of the FFI three subscales according to the score range (0-10), whereas; patients with no pain (0); mild pain (1-3); moderate pain(4-6), and severe or worse pain (7-10).
- Assessment of serum Adiponectin concentration [ Time Frame: 3 months ]The concentrations of serum adiponectin (µg/ml) were measured using human ELISA kit (the Bio-Plex Pro Human Diabetes kit) and measured colorimetrically on the Bio-Plex array reader, according to the manufacturers' instructions.
- Assessment of serum Adenosine deaminase (ADA) activity [ Time Frame: 3 months ]Serum Adenosine deaminase (ADA) activity was measured by colorimetric kit (Tulip diagnostics (P) Ltd, India)
Biospecimen Retention: Samples With DNA