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Completed

NCT Number: NCT07381348

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

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?

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Key information

Conditions

Fibromyalgia Atrophy Muscular Atrophy Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rheumatic Diseases Sarcopenia Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Ankara Bilkent City Hospital Physical Treatment and Rehabilitation Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Fibromyalgia Impact Questionnaire (FIQ)

    Time frame: 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

  2. Hand Grip Strength measured by Hand Dynamometer

    Time frame: baseline

    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)

  3. Skeletal Muscle Mass Index (SMI) measured by Bioimpedance Analysis (BIA)

    Time frame: Baseline

    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

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Collaborators

  • Saglik Bilimleri Universitesi

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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