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

NCT07381348 | Completed

• 1 other identifier: 10025132
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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?

Conditions

Fibromyalgia; Sarcopenia

Keywords

Fibromyalgia; Sarcopenia; Metabolom

Outcome Measures

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.

  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

Secondary Outcomes (3)

• Fibromyalgia Impact Questionnaire (FIQ)

  Baseline (Day 0)

• Hand Grip Strength measured by Hand Dynamometer

  baseline

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

  Baseline

Study Arms (3)

Fibromiyalgia and probable sarcopenia

Fibromyalgia and no probable sarcopenia

Healthy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead
• Saglik Bilimleri Universitesi: collaborator

Study Sites (1)

Ankara Bilkent City Hospital Physical Treatment and Rehabilitation Hospital

Ankara, Ankara, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood serum metabolom analysis

MeSH Terms

Conditions

Fibromyalgia; Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Officials

• Emre Adıgüzel

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emre Adıgüzel, Associate professor, Ankara City Hospital Bilkent

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: February 2, 2026
• Study Start: June 1, 2022
• Primary Completion: November 10, 2022
• Study Completion: May 30, 2023
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)