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

Rheumatoid Arthritis Clinical Trial

Official title:

Foot Bone Mineral Density and Inflammation in Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04036669
• Other study ID #: file ID: RRC-2014-022
• Status: Completed
• Start date: February 20, 2014
• Est. completion date: May 30, 2015

Study information

• Verified date: July 2019
• Source: King Saud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 30, 2015
• Est. primary completion date: April 30, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Healthy Control
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Saud University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Assessment of serum Adenosine deaminase (ADA) activity	Serum Adenosine deaminase (ADA) activity was measured by colorimetric kit (Tulip diagnostics (P) Ltd, India)	3 months