Determination of Metabolomic Profile Differences in Possible Sarcopenia Accompanying Fibromyalgia Syndrome in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Those who cannot take command due to cognitive dysfunction
- •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
研究组 & 干预措施
Fibromiyalgia and probable sarcopenia
Fibromyalgia and no probable sarcopenia
Healthy
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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)
研究者
Emre Adıgüzel
Emre Adıgüzel, Associate professor, Ankara City Hospital Bilkent
Ankara City Hospital Bilkent