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Determination of Metabolomic Profile Differences in Possible Sarcopenia Accompanying Fibromyalgia Syndrome in Women

Determination of Metabolomic Profile Differences in Possible Sarcopenia Accompanying Fibromyalgia Syndrome in Women

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07381348
Enrollment
66
Registered
2026-02-02
Start date
2022-06-01
Completion date
2023-05-30
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia, Sarcopenia

Keywords

Fibromyalgia, Sarcopenia, Metabolom

Brief 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. 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.

Interventions

None listed

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER
Saglik Bilimleri Universitesi
CollaboratorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

1. Being between 18-60 years old 2. Being diagnosed with Fibromyalgia according to ACR 2016 diagnostic criteria 3. Having agreed to participate in the study 4. Healthy controls 5. Being a woman

Exclusion criteria

1. Those who cannot take command due to cognitive dysfunction 2. Pregnancy 3. Those with severe cardiac disease, COPD, malignancy, neuromuscular disease, inflammatory rheumatic disease and organ failure 4. Those with orthopedic disorders that may cause limitation in joint range of motion and/or loss of motor muscle strength 5. Patients using systemic glucocorticoid, ACE-I / ARB, statin, sulfonylurea, allopurinol

Design outcomes

Primary

MeasureTime frameDescription
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.through study completion, an average of 1 yearAssesment 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.

Secondary

MeasureTime frameDescription
Fibromyalgia Impact Questionnaire (FIQ)Baseline (Day 0)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
Hand Grip Strength measured by Hand DynamometerbaselineAssessment 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)
Skeletal Muscle Mass Index (SMI) measured by Bioimpedance Analysis (BIA)BaselineEstimation 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

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATOREmre Adıgüzel

Ankara City Hospital Bilkent

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026