NCT07793747

Brief Summary

Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease associated with a significantly increased risk of cardiovascular disease and metabolic syndrome (MetS). Asprosin is a recently identified adipokine involved in glucose regulation, insulin resistance, and systemic inflammation, but its role in the cardiometabolic complications of RA remains incompletely understood. The purpose of this case-control study is to evaluate and compare serum Asprosin levels among RA patients with metabolic syndrome, RA patients without metabolic syndrome, and healthy control individuals. The study will also assess the association between serum Asprosin concentrations, RA disease activity (DAS28-ESR), and various cardiometabolic risk indices (including TyG index, Atherogenic Index of Plasma, and Castelli risk indices). Participants will undergo a comprehensive clinical assessment, disease activity scoring, physical function evaluation using the Health Assessment Questionnaire (HAQ), and laboratory investigations including fasting blood tests and serum Asprosin measurement via ELISA. Findings from this study may help clarify the pathophysiological role of Asprosin in RA and improve cardiometabolic risk stratification in affected patients.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started Oct 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Nov 2027

First Submitted

Initial submission to the registry

August 26, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

August 31, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 26, 2026

Last Update Submit

August 26, 2026

Conditions

Keywords

AsprosinCardiometabolic RiskDAS28AdipokinesAtherogenic Index of PlasmaTriglyceride-Glucose IndexInsulin Resistance

Outcome Measures

Primary Outcomes (1)

  • Serum Asprosin Level

    Serum asprosin concentration (measured in ng/mL) assessed via a commercial enzyme-linked immunosorbent assay (ELISA) kit to compare rheumatoid arthritis patients with metabolic syndrome versus rheumatoid arthritis patients without metabolic syndrome.

    Baseline

Study Arms (3)

Rheumatoid Arthritis with Metabolic Syndrome

Adult patients diagnosed with rheumatoid arthritis fulfilling the 2010 ACR/EULAR classification criteria who also meet the NCEP ATP III criteria for metabolic syndrome (presence of 3 or more metabolic components). Serum Asprosin levels and cardiometabolic risk indices will be evaluated.

Rheumatoid Arthritis without Metabolic Syndrome

Adult patients diagnosed with rheumatoid arthritis fulfilling the 2010 ACR/EULAR classification criteria who do not meet the NCEP ATP III diagnostic criteria for metabolic syndrome. Serum Asprosin levels and cardiometabolic risk indices will be evaluated.

Healthy Controls

Age- and sex-matched healthy control individuals without rheumatoid arthritis, metabolic syndrome, or systemic inflammatory conditions, recruited for comparative assessment of baseline serum Asprosin levels.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients aged 18 years and older diagnosed with rheumatoid arthritis fulfilling the 2010 ACR/EULAR classification criteria, recruited from the inpatient and outpatient clinics of the Rheumatology, Rehabilitation, and Physical Medicine Department at Assiut University Hospital, along with age- and sex-matched healthy control individuals.

You may qualify if:

  • Adult patients aged 18 years or older.
  • Diagnosis of rheumatoid arthritis fulfilling the 2010 ACR/EULAR classification criteria.
  • Ability and willingness to provide written informed consent.
  • Healthy controls: Age- and sex-matched individuals without rheumatoid arthritis or systemic inflammatory diseases.

You may not qualify if:

  • Presence of other autoimmune diseases or overlap syndromes.
  • Active acute or chronic infectious diseases.
  • Pregnancy or lactation.
  • Current malignancy or previous history of malignancy.
  • Severe hepatic or renal impairment.
  • Receipt of medications primarily prescribed for weight reduction or agents known to markedly alter lipid or glucose metabolism, other than standard rheumatoid arthritis therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, RheumatoidMetabolic SyndromeCardiovascular DiseasesArachnodactylyInsulin Resistance

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Rheumatology, Rehabilitation and Physical medicine

Study Record Dates

First Submitted

August 26, 2026

First Posted

August 31, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

August 31, 2026

Record last verified: 2026-08