Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Saglik Bilimleri Universitesi | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibromiyalgia and probable sarcopenia | |||
| Fibromyalgia and no probable sarcopenia | |||
| Healthy |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline (Day 0) |
| Hand Grip Strength measured by Hand Dynamometer |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Emre Adıgüzel | Ankara City Hospital Bilkent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital Physical Treatment and Rehabilitation Hospital | Ankara | Ankara | Turkey (Türkiye) |
Participants did not want their personal information to be shared.
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 25, 2023 | Jan 25, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
blood serum metabolom analysis
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) |
| 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 | Baseline |
| D009422 |
| Nervous System Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |