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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04036669
Recruitment Status : Completed
First Posted : July 30, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Sami Gabr, 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.


Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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

  2. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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
Blood samples from all participants were obtained following an overnight fast; serum was separated and stored at -80oC until reused for analysis.


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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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).

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Responsible Party: Sami Gabr, clinical Professor, King Saud University
ClinicalTrials.gov Identifier: NCT04036669    
Other Study ID Numbers: file ID: RRC-2014-022
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sami Gabr, King Saud University:
rheumatoid arthritis, adipokines, foot function index, f-BMD
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases