Adipokines as Predictors of Foot Function, Pain, and Disability in Patients With Rheumatoid Arthritis

Completed

• Conditions: Healthy Control; Rheumatoid Arthritis

• Registration Number: NCT04036669
• Lead Sponsor: King Saud University

Brief Summary

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.

Detailed Description

The present study attempts to evaluate the efficacy of adiponectin, ADA, and foot bone mineral density (fBMD) as predictors of the disease progression in patients with rheumatoid arthritis. A total of 80 RA patients and eighty age and sex-matched healthy controls were included in this study.

Study Timeline

• Study Start: 2014-02-20
• Primary Completion: 2015-04-30
• Study Completion: 2015-05-30
• Status Verified: 2019-07
• Study First Submitted: 2019-07-23
• Study First Submitted QC: 2019-07-25
• Last Update Submitted: 2019-07-25
• Study First Posted: 2019-07-30
• Last Update Posted: 2019-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• patients who 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
• Not receiving any drugs affecting the data obtained
• had Normal daily diets

Exclusion Criteria

• Subjects with obvious ischemic heart disease (angina, myocardial infarction, and lead electrocardiogram abnormalities),
• HCV, HBV, chronic liver and kidney diseases, hypothyroidism.
• Drugs (diuretics; oral contraceptives).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Foot Function Index	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).
Estimation of Foot bone mineral density (f-BMD)	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

Secondary Outcome Measures

Name	Time	Method
Assessment of serum Adiponectin concentration	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	3 months	Serum Adenosine deaminase (ADA) activity was measured by colorimetric kit (Tulip diagnostics (P) Ltd, India)