Rheumatoid ArthritisNCT07793747
Serum Asprosin, Metabolic Syndrome, and Cardiometabolic Risk in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis and Metabolic Syndrome, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Metabolic Syndrome, Cardiovascular Diseases
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Association of Serum Asprosin With Metabolic Syndrome and Cardiometabolic Risk in Patients With Rheumatoid Arthritis
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.
- Keywords
- Asprosin, Cardiometabolic Risk, DAS28, Adipokines, Atherogenic Index of Plasma, Triglyceride-Glucose Index, Insulin Resistance
- Medical subject headings
- Arthritis, Rheumatoid, Metabolic Syndrome, Cardiovascular Diseases, Arachnodactyly, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viola Rafaat Shafik Tadros, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793747
- Sponsor's protocol ID
- Asprosin in RA & MetS Risk
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Serum Asprosin With Metabolic Syndrome and Cardiometabolic Risk in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07793747
- Acronym / sponsor ID
- Asprosin in RA & MetS Risk
- Keywords
- Asprosin, Cardiometabolic Risk, DAS28, Adipokines, Atherogenic Index of Plasma, Triglyceride-Glucose Index, Insulin Resistance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum Asprosin Level
Time frame: Baseline
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Metabolic Syndrome, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Asprosin Level (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.