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

Foot Bone Mineral Density and Inflammation in Rheumatoid Arthritis

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Healthy Control

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 Type: Observational
• Enrollment (Actual): 160

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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, and eighty age and sex matched healthy controls were included in the study following assignment of informed consent.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
RA patients; 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
Healthy control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimation of Foot bone mineral density (f-BMD)	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	3 months
Foot Function Index	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).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of serum Adiponectin concentration	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.	3 months
Assessment of serum Adenosine deaminase (ADA) activity	Serum Adenosine deaminase (ADA) activity was measured by colorimetric kit (Tulip diagnostics (P) Ltd, India)	3 months

Collaborators and Investigators

• Sponsor: King Saud University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2014
• Primary Completion (Actual): April 30, 2015
• Study Completion (Actual): May 30, 2015

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 25, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: rheumatoid arthritis, adipokines, foot function index, f-BMD
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: file ID: RRC-2014-022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No