Primary Sjögren SyndromeNCT07804719
Possible Sarcopenia, Sarcopenia, and Functional Status in Patients With Primary Sjögren's Syndrome
An observational study of Primary Sjögren Syndrome and Sarcopenia, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the frequency of probable sarcopenia and sarcopenia in patients with primary Sjögren syndrome and to investigate the effects of sarcopenia on functional status, muscle strength, and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Sjögren Syndrome, Sarcopenia
- What is being tested?
- dexa, hand grip strength, myostatin, follistatin
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2025to 20 Oct 2026
- How long will I take part?
- 1 Year
- 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 120
Who may be able to join
- Voluntarily
- Women over the age of 18
- Women diagnosed with primary Sjögren's syndrome
Who cannot join
- Those with cognitive impairment
- Pregnancy
- Malignancy
- Those with other rheumatic diseases
- Uncontrolled chronic disease(diabetes mellitus, hypertension, hypothyroidism, hyperthyroidism)
- Those who have difficulty walking on their own
Show all 10Show fewer
- Arthritis present in the dominant hand joints
- Central and peripheral nervous system findings
- Myositis and mechanical pain
- Individuals receiving treatment for hyperlipidemia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital
Antalya, Muratpaşa, 07100
About this study
Official title: Investigation of Possible Sarcopenia and/or the Presence of Sarcopenia in Patients With Primary Sjögren's Syndrome and Its Effect on Functional Status
The aim of this study is to evaluate the frequency of probable sarcopenia and sarcopenia in patients with primary Sjögren syndrome and to investigate the effects of sarcopenia on functional status, muscle strength, and quality of life. Adult patients diagnosed with primary Sjögren syndrome will be included in the study. Muscle strength, muscle mass, physical performance, and functional status will be assessed using various evaluation methods
Read the detailed description
Primary Sjögren syndrome is a chronic autoimmune inflammatory disease that may affect the musculoskeletal system. Sarcopenia is characterized by decreased muscle mass and muscle strength and may lead to impaired physical performance and functional capacity.
In this cross-sectional study, the presence of probable sarcopenia and sarcopenia in adult patients with primary Sjögren syndrome will be evaluated. Demographic characteristics, disease duration, and clinical findings of the participants will be recorded. Muscle strength will be assessed using handgrip strength testing, and physical performance will be evaluated using functional performance tests. In addition functional status scales will be administered.
The study aims to determine the effects of sarcopenia on functional status and quality of life in patients with primary Sjögren syndrome.
- Conditions
- Primary Sjögren Syndrome, Sarcopenia
- Being tested
- dexa, hand grip strength, myostatin, follistatin
- Keywords
- primary sjogren syndrome, Sarcopenia, muscle mass, hand grip strength, physical performance, functional status
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexa, hand grip strength, myostatin, follistatinDiagnostic test
Although these parameters are frequently assessed in other rheumatological diseases, few studies have previously examined such a wide range of parameters in patients with primary Sjögren's syndrome.
| Study group | Role | What they receive |
|---|---|---|
| primary sjögren syndrome group | Participants' muscle strength, muscle mass, and physical performance were examined. Receives: Diagnostic Test: dexa, hand grip strength, myostatin, follistatin | |
| Control group | Participants' muscle strength, muscle mass, and physical performance were examined. Receives: Diagnostic Test: dexa, hand grip strength, myostatin, follistatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle strength
Muscle strength will be assessed using hand-held dynamometry. Measurements will be recorded in kilograms-force (kgf) and compared between primary Sjögren syndrome patients and healthy controls.Values below 16 kg will be considered indicative of low muscle strength.
Measured: 12 month
muscle mass
Muscle mass will be assessed using DEXA. Results will be compared between groups.If appendiculer lean mass/height² is below 5.5, it will be considered low muscle mass.
Measured: 12 months
functional status
Functional status will be evaluated using validated functional assessment scales(Five-times sit-to-stand test, Timed Up and Go test, walking speed test, myometer test). Scores will be compared between primary Sjögren syndrome patients and healthy controls.If the five times sit-to-stand test takes longer than 15 seconds, if the walking speed is 0.8 meters/second or lower, if the Timed Up and Go test result is 20 seconds or longer will be considered indicative of low functional status.
Measured: 12 months
Secondary outcomes (2)
myostatin
Serum myostatin levels will be measured using enzyme-linked immunosorbent assay (ELISA) and compared between groups.It will be evaluated whether there is a significant difference in the blood levels of these markers between the patient and control groups.No serum myostatin value range has been established for sarcopenia in existing studies. Therefore, the study will examine whether there is a significant difference in myostatin levels between the patient group and the control group.
Measured: 12 months
follistatin
Serum follistatin levels will be measured using enzyme-linked immunosorbent assay (ELISA) and compared between groups.It will be evaluated whether there is a significant difference in the blood levels of these markers between the patient and control groups.There is no established serum follistatin reference range for sarcopenia in existing studies. Therefore, the study will examine whether there is a significant difference in follistatin levels between the patient group and the control group.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start20 Jul 2025
- Primary completion20 Jul 2025
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sjögren SyndromeStudies of the same condition, open and under way.
- 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
- 120 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mehmet Çetin, Doctor, Study director, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804719
- Sponsor's protocol ID
- 2025-276
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Possible Sarcopenia and/or the Presence of Sarcopenia in Patients With Primary Sjögren's Syndrome and Its Effect on Functional Status
- ClinicalTrials.gov ID
- NCT07804719
- Acronym / sponsor ID
- 2025-276
- Conditions
- Primary Sjögren Syndrome, Sarcopenia
- Keywords
- primary sjogren syndrome, Sarcopenia, muscle mass, hand grip strength, physical performance, functional status
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 20 Jul 2025 (actual)
- Primary completion
- 20 Jul 2025 (actual)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 4 Sep 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.
The aim of this study is to evaluate the frequency of probable sarcopenia and sarcopenia in patients with primary Sjögren syndrome and to investigate the effects of sarcopenia on functional status, muscle strength, and quality of life. Adult patients diagnosed with primary Sjögren syndrome will be included in the study. Muscle strength, muscle mass, physical performance, and functional status will be assessed using various evaluation methods
Detailed description
Primary Sjögren syndrome is a chronic autoimmune inflammatory disease that may affect the musculoskeletal system. Sarcopenia is characterized by decreased muscle mass and muscle strength and may lead to impaired physical performance and functional capacity.
In this cross-sectional study, the presence of probable sarcopenia and sarcopenia in adult patients with primary Sjögren syndrome will be evaluated. Demographic characteristics, disease duration, and clinical findings of the participants will be recorded. Muscle strength will be assessed using handgrip strength testing, and physical performance will be evaluated using functional performance tests. In addition functional status scales will be administered.
The study aims to determine the effects of sarcopenia on functional status and quality of life in patients with primary Sjögren syndrome.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| primary sjögren syndrome group | – | Diagnostic Test: dexa, hand grip strength, myostatin, follistatinParticipants' muscle strength, muscle mass, and physical performance were examined. |
| Control group | – | Diagnostic Test: dexa, hand grip strength, myostatin, follistatinParticipants' muscle strength, muscle mass, and physical performance were examined. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 120
Key inclusion criteria (3 listed)
- Voluntarily
- Women over the age of 18
- Women diagnosed with primary Sjögren's syndrome
Key exclusion criteria (10 listed)
- Those with cognitive impairment
- Pregnancy
- Malignancy
- Those with other rheumatic diseases
- Uncontrolled chronic disease(diabetes mellitus, hypertension, hypothyroidism, hyperthyroidism)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexa, hand grip strength, myostatin, follistatinAlthough these parameters are frequently assessed in other rheumatological diseases, few studies have previously examined such a wide range of parameters in patients with primary Sjögren's syndrome. | Diagnostic test | Control group, primary sjögren syndrome group |
Primary outcome
muscle strength
Time frame: 12 month
Muscle strength will be assessed using hand-held dynamometry. Measurements will be recorded in kilograms-force (kgf) and compared between primary Sjögren syndrome patients and healthy controls.Values below 16 kg will be considered indicative of low muscle strength.
muscle mass
Time frame: 12 months
Muscle mass will be assessed using DEXA. Results will be compared between groups.If appendiculer lean mass/height² is below 5.5, it will be considered low muscle mass.
functional status
Time frame: 12 months
Functional status will be evaluated using validated functional assessment scales(Five-times sit-to-stand test, Timed Up and Go test, walking speed test, myometer test). Scores will be compared between primary Sjögren syndrome patients and healthy controls.If the five times sit-to-stand test takes longer than 15 seconds, if the walking speed is 0.8 meters/second or lower, if the Timed Up and Go test result is 20 seconds or longer will be considered indicative of low functional status.
2 secondary outcomes
myostatin
Time frame: 12 months
follistatin
Time frame: 12 months
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 26 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Mehmet Çetin, Doctor study director
Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Sjögren Syndrome and Sarcopenia, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
muscle strength (time frame: 12 month). The study lists 3 primary outcomes in all. 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 26 Oct 2026.