FibromyalgiaNCT07381348
Determination of Metabolomic Profile Differences in Possible Sarcopenia Accompanying Fibromyalgia Syndrome in Women
An observational study of Fibromyalgia and Sarcopenia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to determine the serum metabolome profile differences in the presence of possible sarcopenia in patients with fibromyalgia and to compare them with healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Sarcopenia
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 30 May 2023
- How long will I take part?
- 1 Day
- 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Forty-four female patients aged 18-60 years and 22 healthy female controls who applied to the physical therapy outpatient clinics of Ankara City Hospital FTR hospital and were diagnosed with Fibromyalgia according to the American Rheumatology Society (ACR) 2016 diagnostic criteria.
Who may be able to join
- Being between 18-60 years old
- Being diagnosed with Fibromyalgia according to ACR 2016 diagnostic criteria
- Having agreed to participate in the study
- Healthy controls
- Being a woman
Who cannot join
- Those who cannot take command due to cognitive dysfunction
- Pregnancy
- Those with severe cardiac disease, COPD, malignancy, neuromuscular disease, inflammatory rheumatic disease and organ failure
- Those with orthopedic disorders that may cause limitation in joint range of motion and/or loss of motor muscle strength
- Patients using systemic glucocorticoid, ACE-I / ARB, statin, sulfonylurea, allopurinol
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital Physical Treatment and Rehabilitation Hospital
Ankara, Ankara
About this study
The goal of this observational study is to determine the serum metabolome profile differences in the presence of possible sarcopenia in patients with fibromyalgia and to compare them with healthy individuals. In this way, it is aimed to contribute to the knowledge about the pathophysiology, diagnosis and treatment of these diseases.The main questions it aims to answer are:
- Is there a difference in blood metabolite levels and metabolic pathways in fibromyalgia syndrome and possible sarcopenia accompanying fibromyalgia syndrome?
- Based on these identified differences, can biomarkers be determined for these diseases?
Read the detailed description
After being informed about study and potential risks, all patient giving written informed consent will undergo screening period determine eligibility for study entry. Participants will be divided into three groups: those with fibromyalgia syndrome and probable sarcopenia, those with fibromyalgia syndrome and no probable sarcopenia, and healthy people. Presence of probable sarcopenia and sarcopenia will be determined by using SARC-F scale, hand grip strength measurement with hand dynamometer, muscle mass measurement with Bioimpedance Analysis, anthropometric measurement, walking speed measurement in patients with fibromyalgia diagnosis.The serum metabolome profiles of the three groups will be compared.
- Conditions
- Fibromyalgia, Sarcopenia
- Keywords
- Fibromyalgia, Sarcopenia, Metabolom
- Medical subject headings
- Fibromyalgia, Sarcopenia
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 |
|---|---|---|
| Fibromiyalgia and probable sarcopenia | Not described | |
| Fibromyalgia and no probable sarcopenia | Not described | |
| Healthy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of serum metabolite concentrations between groups. Plasma samples were collected from all participants. Samples were centrifuged at 1500 rpm for 10 minutes and stored at -80 degrees to be used in metabolome analysis.
Assesment of serum metabolite concentrations using gas chromatography/mass spectroscopy (GC/MS).
The obtained GC/MS data were evaluated on the MS-DIAL metabolomics platform. Untargeted metabolomics studies have been conducted. Metabolites with a match score of 70 and above were accepted using the Kovats retention index database. In the pre-data analysis processes within the MS DIAL platform, peak identification, deconvolution and data alignment processes were primarily carried out. After comparing the metabolome data between the three groups, cluster analysis was performed and pathway differences between the groups were revealed. The results were evaluated at the 95% confidence interval and the significance level was p<0.05.
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Fibromyalgia Impact Questionnaire (FIQ)
A self-administered instrument used to measure the health status of patients with fibromyalgia. Scores range from 0 to 100, where higher scores indicate a greater impact of the syndrome on the patient's life.
Units on a scale
Measured: Baseline (Day 0)
Hand Grip Strength measured by Hand Dynamometer
Assessment of upper extremity muscle strength using a hydraulic hand dynamometer (e.g., Jamar). Participants perform three trials with the dominant hand, and the maximum value is recorded.
Unit of Measure: Kilograms (kg)
Measured: baseline
Skeletal Muscle Mass Index (SMI) measured by Bioimpedance Analysis (BIA)
Estimation of skeletal muscle mass using a multi-frequency BIA device. The Skeletal Muscle Index (SMI) is calculated by dividing the appendicular skeletal muscle mass by the square of the height (kg/m²).
Unit of Measure: kg/m^2
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Jun 2022
- Primary completion10 Nov 2022
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- 66 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Responsible party
- Principal investigator, Emre Adıgüzel, Ankara City Hospital Bilkent
- Investigators
- Emre Adıgüzel, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381348
- Sponsor's protocol ID
- 10025132
- Status last verified
- Jan 2026
- First submitted
- 23 Nov 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants did not want their personal information to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Metabolomic Profile Differences in Possible Sarcopenia Accompanying Fibromyalgia Syndrome in Women
- ClinicalTrials.gov ID
- NCT07381348
- Acronym / sponsor ID
- 10025132
- Conditions
- Fibromyalgia, Sarcopenia
- Keywords
- Fibromyalgia, Sarcopenia, Metabolom
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 2 Feb 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 goal of this observational study is to determine the serum metabolome profile differences in the presence of possible sarcopenia in patients with fibromyalgia and to compare them with healthy individuals. In this way, it is aimed to contribute to the knowledge about the pathophysiology, diagnosis and treatment of these diseases.The main questions it aims to answer are:
- Is there a difference in blood metabolite levels and metabolic pathways in fibromyalgia syndrome and possible sarcopenia accompanying fibromyalgia syndrome?
- Based on these identified differences, can biomarkers be determined for these diseases?
Detailed description
After being informed about study and potential risks, all patient giving written informed consent will undergo screening period determine eligibility for study entry. Participants will be divided into three groups: those with fibromyalgia syndrome and probable sarcopenia, those with fibromyalgia syndrome and no probable sarcopenia, and healthy people. Presence of probable sarcopenia and sarcopenia will be determined by using SARC-F scale, hand grip strength measurement with hand dynamometer, muscle mass measurement with Bioimpedance Analysis, anthropometric measurement, walking speed measurement in patients with fibromyalgia diagnosis.The serum metabolome profiles of the three groups will be compared.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fibromiyalgia and probable sarcopenia | – | – |
| Fibromyalgia and no probable sarcopenia | – | – |
| Healthy | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Forty-four female patients aged 18-60 years and 22 healthy female controls who applied to the physical therapy outpatient clinics of Ankara City Hospital FTR hospital and were diagnosed with Fibromyalgia according to the American Rheumatology Society (ACR) 2016 diagnostic criteria.
Key inclusion criteria (5 listed)
- Being between 18-60 years old
- Being diagnosed with Fibromyalgia according to ACR 2016 diagnostic criteria
- Having agreed to participate in the study
- Healthy controls
- Being a woman
Key exclusion criteria (5 listed)
- Those who cannot take command due to cognitive dysfunction
- Pregnancy
- Those with severe cardiac disease, COPD, malignancy, neuromuscular disease, inflammatory rheumatic disease and organ failure
- Those with orthopedic disorders that may cause limitation in joint range of motion and/or loss of motor muscle strength
- Patients using systemic glucocorticoid, ACE-I / ARB, statin, sulfonylurea, allopurinol
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
Comparison of serum metabolite concentrations between groups. Plasma samples were collected from all participants. Samples were centrifuged at 1500 rpm for 10 minutes and stored at -80 degrees to be used in metabolome analysis.
Time frame: through study completion, an average of 1 year
Assesment of serum metabolite concentrations using gas chromatography/mass spectroscopy (GC/MS). The obtained GC/MS data were evaluated on the MS-DIAL metabolomics platform. Untargeted metabolomics studies have been conducted. Metabolites with a match score of 70 and above were accepted using the Kovats retention index database. In the pre-data analysis processes within the MS DIAL platform, peak identification, deconvolution and data alignment processes were primarily carried out. After comparing the metabolome data between the three groups, cluster analysis was performed and pathway differences between the groups were revealed. The results were evaluated at the 95% confidence interval and the significance level was p<0.05.
3 secondary outcomes
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: Baseline (Day 0)
Hand Grip Strength measured by Hand Dynamometer
Time frame: baseline
Skeletal Muscle Mass Index (SMI) measured by Bioimpedance Analysis (BIA)
Time frame: Baseline
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 2 Feb 2026.
- Individual participant dataSharing planned: No. Participants did not want their personal information to be shared.
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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.
Emre Adıgüzel principal investigator
Ankara City Hospital Bilkent
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 Fibromyalgia and Sarcopenia, run by Ankara City Hospital Bilkent 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 5 inclusion and 5 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 2 Feb 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?
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?
Comparison of serum metabolite concentrations between groups. Plasma samples were collected from all participants. Samples were centrifuged at 1500 rpm for 10 minutes and stored at -80 degrees to be used in metabolome analysis. (time frame: through study completion, an average of 1 year). 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 2 Feb 2026.