RecruitingNCT04832100

Bio-significance of LPC16:0 in Fibromyalgia

A Clinical Approach to Validate the Biological Significance of LPC16:0 as a Discriminating and Pathogenic Biomarker of Fibromyalgia


Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Enrollment

245 participants

Start Date

Jun 1, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

Fibromyalgia (FM) is a very common but mysterious pain disorder characterized by chronic widespread muscular pain. Fatigue, anxiety and depression are common comorbidities. The syndrome is commonly associated with several symptoms, including fatigue, sleeping disturbance, cognitive impairment, and comorbid pain syndrome, especially irritable bowel symptoms and temporomandibular disease. Anxiety and depression are common psychiatric co-morbidies. Daily stress is believed to trigger or aggravate pain conditions. These symptoms can markedly affect patients' quality of life, and even lead to disability. So far, the etiology and pathogenesis are largely unknown, and diagnostic biomarkers and curative treatment remain to be developed. Recent technological advances enable scientists to explore mechanisms by genetic, transcriptomic, proteomic, and metabolomic researches. However, no definitive result has been concluded for clinical practice so far. In this study, the investigators use tailored questionnaires to evaluate fibromyalgia and associated symptoms, including numeric rating scale for soreness, widespread soreness index, Fibromyalgia impact questionnaire, Hospital Anxiety and Depression Scale, and perceived stress scale. The investigators also use metabolomics and lipidomic approach to probe the potential pathophysiology of fibromyalgia. In our prior translation research (PMID: 32907805), the investigators found that excessive LPC16:0 resulting from lipid oxidization inflicts psychological stress-induced chronic non-inflammatory pain via activating ASIC3. In this content, our prior translational research identified a potential nociceptive ligand that causes fibromyalgia symptoms, which is likely to function as biomarkers for diagnosis or disease monitor. In the current clinical investigation, the investigators aim to reversely translate the novel findings in animal studies and validate the bio-significance of LPC16:0 for fibromyalgia with clinical approaches.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating a specific molecule called LPC16:0 (a type of lipid or fat molecule) to understand its role in fibromyalgia — a chronic condition characterized by widespread musculoskeletal pain, fatigue, and sleep problems. The biological causes of fibromyalgia are still poorly understood, and researchers believe certain lipid molecules in the blood may serve as biomarkers (measurable indicators) of the condition. Participants with a confirmed fibromyalgia diagnosis will have blood samples collected and analyzed for LPC16:0 levels and other related markers. The findings could open doors to better diagnostic tools and eventually new treatments for fibromyalgia. You may be eligible if: - You are between 18 and 70 years old - You have a clinical diagnosis of fibromyalgia You may NOT be eligible if: - You have a systemic rheumatological or autoimmune disorder (e.g., lupus, inflammatory myositis) - You use systemic (oral or injected) corticosteroids - You are pregnant - You have a chronic disease that is poorly controlled - You have a current malignancy (cancer) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPregabalin 150mg, imipramine 25mg

Conventional treatment for fibromyalgia was given to patients. Clinical follow-ups with questionnaires and interview were arranged then.


Locations(1)

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

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NCT04832100


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