SarcopeniaNCT05015114
Prevalence and Factors of Sarcopenia and in Patients With Primary Sjogren's Syndrome
An observational study of Sarcopenia and Sjogren's Syndrome, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
Sarcopenia is a progressive condition characterized by decline in muscle strength and muscle mass. Although the mechanism of sarcopenia has not been fully elucidated, it may be caused by protein-poor diet, vitamin D deficiency, hormonal changes, increase in inflammatory cytokine level and oxidative stress. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Sarcopenia, Sjogren's Syndrome, Rheumatologic Disease
- What is being tested?
- Sarcopenia Assessment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Aug 2021to 5 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 70 years
- All sexes
- Adult, Older adult
Study population: Patients with primary Sjogren's syndrome
Who may be able to join
- Diagnosed with primary Sjogren's syndrome by an experienced rheumatologist according to European League Against Rheumatism (EULAR) ve American College of Rheumatology (ACR) criteria
- Being 40 years or older.
Who cannot join
- Pregnancy,
- Malignancy,
- Presence of other rheumatological diseases,
- Presence of diabetes mellitus
- Presence of neurological problems
- Presence of osteoarthritis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haydarpasa Numune Research and Training Hospital
Istanbul
About this study
Official title: Prevalence and Factors of Sarcopenia in Patients With Primary Sjogren's Syndrome
Sarcopenia is a progressive condition characterized by decline in muscle strength and muscle mass. Although the mechanism of sarcopenia has not been fully elucidated, it may be caused by protein-poor diet, vitamin D deficiency, hormonal changes, increase in inflammatory cytokine level and oxidative stress. For this reason, it is thought that determining the prevalence of sarcopenia in rheumatological diseases with chronic inflammation and protecting patients from possible comorbidities with appropriate interventions may be an important factor in maintaining and improving the functional levels and quality of life of patients.
The aim of our study was to investigate the prevalence and its associated factors of sarcopenia in individuals with primary Sjögren's Syndrome.
- Conditions
- Sarcopenia, Sjogren's Syndrome, Rheumatologic Disease
- Being tested
- Sarcopenia Assessment
- Medical subject headings
- Sarcopenia, Sjogren's Syndrome, Collagen Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sarcopenia AssessmentOther
Sarcopenia Assessment
| Study group | Role | What they receive |
|---|---|---|
| Primary Sjogren's Syndrome | Participants with Primary Sjogren's Syndrome Receives: Other: Sarcopenia Assessment | |
| Control group | Healthy controls Receives: Other: Sarcopenia Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Mass
Muscle mass will be calculated via bioimpedance analysis method. Fat Free Mass will be recorded using TANITA BC 532 Bioimpedance Device and Skeletal Muscle Mass and Skeletal Muscle Mass will be calculated.
Measured: 1 day
Grip Strength
Grip strength will be evaluated with JAMAR dynamometer. The patient is positioned in a chair with the elbow flexed to 90 degrees and the wrist in a neutral position, and he/she is asked to grip as strong as he/she can do for 3 seconds. The test is repeated 3 times and the highest value is recorded.
Measured: 1 day
Gait Speed
The patient will be asked to walk 4-meters for two times. The shortest time to walk through this distance will be recorded.
Measured: 1 day
5 Times Sit to Stand Test
This test includes the calculation of the time it takes to sit and get up from the chair 5 times while the arms are crossed over the shoulders.
Measured: 1 day
Secondary outcomes (3)
EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
ESSDAI was developed to determine the disease activity level specifically for Sjogren's Syndrome. It includes 12 domains (ie, organ systems: cutaneous, respiratory, renal, articular, muscular, peripheral nervous system (PNS), central nervous system (CNS), haematological, glandular, constitutional, lymphadenopathic, biological). Each domain is divided into 3-4 levels of activity. A score less than 5 indicates a low level of disease, a score between 5 and 13 indicates a moderate level, and a score of more than 14 indicates a high level of active 14. It is a scoring system that evaluates every domain between 0 and 3.
Measured: 1 day
EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
The patient is asked to define the level of fatigue, pain and dryness symptoms with a score between 1 and 10, and the average of the score obtained from these three questions are recorded. An ESSPRI score of less than 5 was considered an acceptable disease state, while a score of 5 or above was considered a sign of high activity.
Measured: 1 day
Malnutrition Evaluation
The presence of malnutrition in the participants will be evaluated with the Mini Nutritional Assessment Form (Short Form). This form consists of 6 questions including loss of appetite, weight loss, mobility, stress or acute illness, dementia or depression, and body mass index. The total score ranges from 0 to 14, with 12 and above meaning "normal nutritional status", 8 to 11 "malnutrition risk" and 0 to 7 meaning malnutrition.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start12 Aug 2021
- Primary completion5 May 2022
- Study completion5 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Acibadem 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgül Öztürk, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015114
- Sponsor's protocol ID
- ATADEK - 2021/10
- Status last verified
- May 2022
- First submitted
- 12 Aug 2021
- Last updated
- 25 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Factors of Sarcopenia in Patients With Primary Sjogren's Syndrome
- ClinicalTrials.gov ID
- NCT05015114
- Acronym / sponsor ID
- ATADEK - 2021/10
- Conditions
- Sarcopenia, Sjogren's Syndrome, Rheumatologic Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 20 Aug 2021 (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.
Sarcopenia is a progressive condition characterized by decline in muscle strength and muscle mass. Although the mechanism of sarcopenia has not been fully elucidated, it may be caused by protein-poor diet, vitamin D deficiency, hormonal changes, increase in inflammatory cytokine level and oxidative stress. For this reason, it is thought that determining the prevalence of sarcopenia in rheumatological diseases with chronic inflammation and protecting patients from possible comorbidities with appropriate interventions may be an important factor in maintaining and improving the functional levels and quality of life of patients.
The aim of our study was to investigate the prevalence and its associated factors of sarcopenia in individuals with primary Sjögren's Syndrome.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Sjogren's Syndrome | – | Other: Sarcopenia AssessmentParticipants with Primary Sjogren's Syndrome |
| Control group | – | Other: Sarcopenia AssessmentHealthy controls |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with primary Sjogren's syndrome
Key inclusion criteria (2 listed)
- Diagnosed with primary Sjogren's syndrome by an experienced rheumatologist according to European League Against Rheumatism (EULAR) ve American College of Rheumatology (ACR) criteria
- Being 40 years or older.
Key exclusion criteria (6 listed)
- Pregnancy,
- Malignancy,
- Presence of other rheumatological diseases,
- Presence of diabetes mellitus
- Presence of neurological problems
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 |
|---|---|---|
| Sarcopenia AssessmentSarcopenia Assessment | Other | Control group, Primary Sjogren's Syndrome |
Primary outcome
Muscle Mass
Time frame: 1 day
Muscle mass will be calculated via bioimpedance analysis method. Fat Free Mass will be recorded using TANITA BC 532 Bioimpedance Device and Skeletal Muscle Mass and Skeletal Muscle Mass will be calculated.
Grip Strength
Time frame: 1 day
Grip strength will be evaluated with JAMAR dynamometer. The patient is positioned in a chair with the elbow flexed to 90 degrees and the wrist in a neutral position, and he/she is asked to grip as strong as he/she can do for 3 seconds. The test is repeated 3 times and the highest value is recorded.
Gait Speed
Time frame: 1 day
The patient will be asked to walk 4-meters for two times. The shortest time to walk through this distance will be recorded.
5 Times Sit to Stand Test
Time frame: 1 day
This test includes the calculation of the time it takes to sit and get up from the chair 5 times while the arms are crossed over the shoulders.
3 secondary outcomes
EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
Time frame: 1 day
EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
Time frame: 1 day
Malnutrition Evaluation
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: No
Related trials for Sarcopenia
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sarcopenia and Sjogren's Syndrome, run by Acibadem University 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 2 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: finished, as of the sponsor's last update on 25 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Mass (time frame: 1 day). The study lists 4 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 25 May 2022.