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

NCT04036669 | Completed

• 1 other identifier: file ID: RRC-2014-022
• Study Type: observational
• Target: 160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis; Healthy Control

Keywords

rheumatoid arthritis, adipokines, foot function index, f-BMD

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Assessment of serum Adiponectin concentration

  3 months

• Assessment of serum Adenosine deaminase (ADA) activity

  3 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• King Saud University: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples from all participants were obtained following an overnight fast; serum was separated and stored at -80oC until reused for analysis.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical Professor

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: July 30, 2019
• Study Start: February 20, 2014
• Primary Completion: April 30, 2015
• Study Completion: May 30, 2015
• Last Updated: July 30, 2019

Record last verified: 2019-07