Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-31 @ 11:40 AM
Study NCT ID:
NCT04832100
Status:
RECRUITING
Last Update Posted:
2025-06-26
First Post:
2021-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bio-significance of LPC16:0 in Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D063806', 'term': 'Myalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}, {'id': 'D007099', 'term': 'Imipramine'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-07-01', 'size': 53865, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-10T00:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'collection of blood samples for metabolomic and genetic investigations'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 245}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-22', 'studyFirstSubmitDate': '2021-03-26', 'studyFirstSubmitQcDate': '2021-04-01', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionnaire: Numeric rating scale (NRS) for pain and soreness', 'timeFrame': 'Changes from baseline NRS at 2 weeks are assessed', 'description': 'assessment of pain and soreness severity. Score: 0(no symptom) \\~10 (worst symptom)'}, {'measure': 'Questionnaire: Numeric rating scale (NRS) for pain and soreness', 'timeFrame': 'Changes from baseline NRS at 4 weeks are assessed', 'description': 'assessment of pain and soreness severity. Score: 0(no symptom) \\~10 (worst symptom)'}, {'measure': 'Questionnaire: widespread pain index and widespread soreness index', 'timeFrame': 'Change from baseline widespread index at 2 weeks are assessed', 'description': 'assessment of pain and soreness diffuseness. Score: 0(no symptom) \\~19 (mostly diffused symptom)'}, {'measure': 'Questionnaire: widespread pain index and widespread soreness index', 'timeFrame': 'Change from baseline widespread index at 4 weeks are assessed', 'description': 'assessment of pain and soreness diffuseness. Score: 0(no symptom) \\~19 (mostly diffused symptom)'}, {'measure': 'Questionnaire: Fibromyalgia impact questionnaire (FIQR)', 'timeFrame': 'Change from baseline FIQR at 2 weeks are assessed', 'description': 'assessment of fibromyalgia impacts and disease severity. Score: 0(no symptom) \\~100 (worst symptom)'}, {'measure': 'Questionnaire: Fibromyalgia impact questionnaire (FIQR)', 'timeFrame': 'Change from baseline FIQR at 4 weeks are assessed', 'description': 'assessment of fibromyalgia impacts and disease severity. Score: 0(no symptom) \\~100 (worst symptom)'}, {'measure': 'Questionnaire: Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Change from baseline HADS at 2 weeks are assessed', 'description': 'assessment of psychological distress. Score: 0 (no symptom) \\~42 (worst symptom)'}, {'measure': 'Questionnaire: Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Change from baseline HADS at 4 weeks are assessed', 'description': 'assessment of psychological distress. Score: 0 (no symptom) \\~42 (worst symptom)'}, {'measure': 'Questionnaire: The Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'Change from baseline PSQI at 2 weeks are assessed', 'description': 'assessment of sleep quality. Score: 0 (no symptom) \\~21 (worst sleep quality)'}, {'measure': 'Questionnaire: The Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'Change from baseline PSQI at 4 weeks are assessed', 'description': 'assessment of sleep quality. Score: 0 (no symptom) \\~21 (worst sleep quality)'}, {'measure': 'Questionnaire: Perceived stress scale (PSS)', 'timeFrame': 'Change from baseline PSS at 2 weeks are assessed', 'description': 'assessment of perceived stress loading. Score: 0 (no stress) \\~40 (highest stressed level)'}, {'measure': 'Questionnaire: Perceived stress scale (PSS)', 'timeFrame': 'Change from baseline PSS at 4 weeks are assessed', 'description': 'assessment of perceived stress loading. Score: 0 (no stress) \\~40 (highest stressed level)'}, {'measure': 'Metabolomics investigation', 'timeFrame': 'Change from baseline metabolomics at 3 months are assessed', 'description': 'Laboratory investigation of metabolomic expression, including lactate, creatine, malondialdehyde, protein carbonyls and amino acids.'}, {'measure': 'Lipidomics investigation', 'timeFrame': 'Change from baseline metabolomics at 3 months are assessed', 'description': 'Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.'}, {'measure': 'Metabolomics investigation', 'timeFrame': 'Change from baseline metabolomics at 6 months are assessed', 'description': 'Laboratory investigation of metabolomic expression, including lactate, creatine, malondialdehyde, protein carbonyls and amino acids.'}, {'measure': 'Lipidomics investigation', 'timeFrame': 'Change from baseline metabolomics at 6 months are assessed', 'description': 'Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.'}, {'measure': 'Metabolomics investigation', 'timeFrame': 'Change from baseline metabolomics at 9 months are assessed', 'description': 'Laboratory investigation of metabolomic expression, including lactate, creatine, malondialdehyde, protein carbonyls and amino acids.'}, {'measure': 'Lipidomics investigation', 'timeFrame': 'Change from baseline metabolomics at 9 months are assessed', 'description': 'Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.'}, {'measure': 'Metabolomics investigation', 'timeFrame': 'Change from baseline metabolomics at 12 months are assessed', 'description': 'Laboratory investigation of metabolomic expression, including lactate, creatine, malondialdehyde, protein carbonyls and amino acids.'}, {'measure': 'Lipidomics investigation', 'timeFrame': 'Change from baseline metabolomics at 12 months are assessed', 'description': 'Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lysophosphotidylcholine', 'fibromyalgia', 'pain', 'soreness', 'metabolomics'], 'conditions': ['Fibromyalgia, Primary', 'Pain', 'Soreness, Muscle', 'Oxidative Stress', 'Metabolomics', 'Lipidomics']}, 'referencesModule': {'references': [{'pmid': '36918228', 'type': 'DERIVED', 'citation': 'Hung CH, Tsai MH, Wang PS, Liang FW, Hsu CY, Lee KW, Fong YO, Han DS, Lee CH, Lai CL, Chen CC. Oxidative stress involves phenotype modulation of morbid soreness symptoms in fibromyalgia. RMD Open. 2023 Mar;9(1):e002741. doi: 10.1136/rmdopen-2022-002741.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nIn 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient group: participants with primary fibromyalgia Control group: healthy controls', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Clinical diagnosis of fibromyalgia\n\nExclusion Criteria:\n\n1. Systemic rheumatological or immune disorders (e.g., systemic lupus erythematosus, inflammatory myositis),\n2. Systemic use of corticosteroids,\n3. Pregnancy,\n4. Chronic diseases under poor control\n5. Malignancies.'}, 'identificationModule': {'nctId': 'NCT04832100', 'briefTitle': 'Bio-significance of LPC16:0 in Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'A Clinical Approach to Validate the Biological Significance of LPC16:0 as a Discriminating and Pathogenic Biomarker of Fibromyalgia', 'orgStudyIdInfo': {'id': 'KMUHIRB-G(I)-20170012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with primary fibromyalgia', 'description': 'Adults with complaints of chronic widespread pain at the outpatient department of KMUH were consecutively enrolled over a 5-year period from June 2021 to June 2026. Participants were interviewed by experienced neurologists , and those who fulfilled the 2011 American College of Rheumatology (ACR) criteria for FM were recruited .', 'interventionNames': ['Drug: Pregabalin 150mg, imipramine 25mg']}, {'label': 'Healthy controls', 'description': 'Age- and sex-matched subjects without pain and soreness were also prospectively recruited as healthy controls.'}], 'interventions': [{'name': 'Pregabalin 150mg, imipramine 25mg', 'type': 'DRUG', 'description': 'Conventional treatment for fibromyalgia was given to patients. Clinical follow-ups with questionnaires and interview were arranged then.', 'armGroupLabels': ['Patients with primary fibromyalgia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80756', 'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chih-Hsien Hung', 'role': 'CONTACT', 'email': 'jasonhung0701@hotmail.com', 'phone': '073121101', 'phoneExt': '5851'}, {'name': 'Chih-Hsien Hung, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaohsiung Medical University Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Raw and analyzed data will be shared upon written request to the corresponding author from any qualified investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}