Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT06206694
Status:
COMPLETED
Last Update Posted:
2025-06-06
First Post:
2024-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum YKL-40 Levels is Associated With Nutritional and Oxidative Status of Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 226}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2024-01-04', 'studyFirstSubmitQcDate': '2024-01-12', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of biomarkers of YKL40', 'timeFrame': '1 years', 'description': 'YKL40 is also reportedly useful as an inflammation marker in HD patients'}, {'measure': 'Evaluation of nutritional status and body composition', 'timeFrame': '1 years', 'description': 'Malnutrition, with a prevalence between 40% and 75% in maintenance hemodialysis patients is the most important risk factor for morbidity, the quality of life, all-cause mortality and cardiovascular mortality.'}], 'secondaryOutcomes': [{'measure': 'Analysis of biomarkers of IL-6', 'timeFrame': '1 years', 'description': 'The IL-6 was determined from plasma samples using standardized enzymelinked immunosorbent assay (ELISA) methods'}, {'measure': 'vaspin', 'timeFrame': '1 years', 'description': 'The vaspin was determined from plasma samples using standardized enzymelinked immunosorbent assay (ELISA) methods'}, {'measure': 'insulin', 'timeFrame': '1 years', 'description': 'The insulin was determined from plasma samples using standardized enzymelinked immunosorbent assay (ELISA) methods'}, {'measure': 'adiponectin', 'timeFrame': '1 years', 'description': 'The adiponectin was determined from plasma samples using standardized enzymelinked immunosorbent assay (ELISA) methods'}, {'measure': 'total antioxidant capacity', 'timeFrame': '1 years', 'description': 'Total antioxidant capacityassay is useful to assay antioxidant levels in serum'}, {'measure': 'AOPP', 'timeFrame': '1 years', 'description': 'The IL-6 was determined from plasma samples using standardized enzymelinked immunosorbent assay (ELISA) methods'}, {'measure': 'Nε-Carboxymethyllysine (CML)', 'timeFrame': '1 years', 'description': 'The Nε-Carboxymethyllysine (CML) was determined from plasma samples using standardized enzymelinked immunosorbent assay (ELISA) methods'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['YKL-40', 'nutrition status', 'hemodialysis patients', 'inflammation'], 'conditions': ['Malnutrition', 'Oxidative Stress']}, 'descriptionModule': {'briefSummary': 'Background\n\nYKL-40 is a glycoprotein that had been reported to be associated with inflammation atherosclerosis and endothelial dysfunction. The objective is to explore the association of serum YKL-40 levels with nutrition status, inflammation, and body composition in a cohort of hemodialysis patients\n\nMethods\n\nWe plan to recruit 400 prevalent HD patients. Their baseline serum YKL-40 levels, body anthropometry, the profile of insulin resistance, bioimpedance spectroscopy parameters, and nutritional indices will be measured.', 'detailedDescription': "Study Design and Patients\n\nPatients This is a prospective observational study. The patients will be recruited from HD patients at dialysis units of Tungs Taichung Metroharbour Hospital, which is an outpatient facility. The study inclusion criteria of participants are those maintain on HD therapy for at least 3 months prior to enrollment and being in stable condition without co-morbidities such as heart failure, infection, cirrhosis, respiratory disease, nephrotic syndrome, malignancy, chronic liver disease, or severe inflammation. None of the patients are receiving surgical operations or hospitalized in recent 3 months. In this study, written informed consent will be obtained from all participants. The study protocol will be send to the institutional review board of Tungs Taichung Metroharbour Hospital for approval. The study will be registered to the ClinicalTrial. Gov. Registry and will fully adhered to the guidelines of the Declaration of Helsinki\n\nMethodology\n\nLaboratory measurements Blood samples will be collected before dialysis session. Serum biochemistry such as albumin, urea nitrogen, uric acid, creatinine, total cholesterol, triacylglycerol levels, total ion binding capacity (TIBC), 25-hydroxyvitamin D, hemoglobin, and white blood count are measured employing standard laboratory techniques with the use of an automatic analyzer. Serum prealbumin and high-sensitivity C-reactive protein (hs-CRP) are quantified by nephelometry. YKL-40 and interleukin-6 (IL-6) were quantified by a double-sided sandwich-type enzyme-linked immunosorbent assay (ELISA) kit (R\\&D Systems ; Minneapolis, MN, USA).\n\nFasting glucose levels were measured, after overnight fast and classified according to the American Diabetes Association (ADA) standards \\[29\\]. In addition, the serum insulin level, and hemoglobin A1c level are measured. The assessment of insulin resistance is done using the HOMA-IR index \\[30\\]: HOMA - IR = fasting glucose (in mmol/l) × fasting insulin (in µU/ml) / 22.5 Serum insulin, vaspin, and adiponectin level is measured by a commercially available ELISA kit following the manufacturer's instructions. Markers of oxidative stress such as total antioxidant capacity \\[TAC\\]), serum advanced oxidation protein products (AOPP) and serum CML (a component of AGEs) will also be measured.\n\nEvaluation of nutritional status and body composition\n\nAnthropometric measures including body weight, body mass index (BMI), waist and hip circumference, mid-arm circumference, and the waist-hip ratio (WHR) will be obtained. BMI is determined by the standard formula and further categorized according to the Asia Pacific version of the WHO classification \\[31-32\\]. According to this system, BMI\\<18 kg/m2 is underweight; 18 to 22.9 is normal weight; 23 to 24.9 is marginal overweight; 25 to 29.9 is overweight; and greater than 30 is obesity \\[27, 28\\]. Lastly, the conicity index at baseline is determined to quantify the degree of central obesity \\[33\\].\n\nPatients' nutrition status is determined by their serum albumin and pre-albumin levels, Subjective Global Assessment (SGA) score, normalized protein nitrogen appearance (NPNA), and fat-free edema-free body mass (FEBM). The 4-item 7-point SGA scoring system is employed \\[34\\]. NPNA was calculated using the modifed Bergstrom's formula \\[35\\]. FEBM was calculated using the creatinine kinetic method following the Forbes and Brunining formula \\[36\\], and reported as a percentage of their ideal body weight.\n\nWe use the multi-frequency bio-impedance spectroscopy device (Body Composition Monitor, Fresenius Medical Care, Germany) as described previously \\[36, 37\\]. In this study, the data on lean tissue mass (LTM), adipose tissue mass (ATM), the volume of over-hydration (OH), and the extracellular-tointracellular volume (E: I) ratio will be analyzed.\n\nStatistical analysis All variables were analysed using a Kolmogorov-Smirnov test to classify them as normally or non-normally distributed. Values are given as mean \\[standard deviation (SD)\\] or median (IQR). Univariate analysis is performed to examine the relationships between YKL-40 and other parameters employing Spearman's rank correlation coefficient. Multivariate analysis is performed for parameters showing significant differences. Potential confounding factors for increased YKL-40 are assessed using a multiple regression analysis model based on general variables, inflammatory markers and correlations with malnutrition (p\\<0.10). Two-sided P values of \\<0.05 are considered to be statistically significant in all analyses. All statistical analyses were performed with the SPSS 23.0 statistical package (SPSS, Chicago, IL, USA). A p-value \\<0.05 is considered statistically significant."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients have to be at least 20-years-old and hemodialysis (HD) for at least 3 months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both sexes aged 20 years or over\n* Received stable hemodialysis at least 3 months.\n* Written informed consent.\n\nExclusion Criteria:\n\n* heart failure\n* infection\n* cirrhosis\n* respiratory disease\n* nephrotic syndrome\n* malignancy\n* chronic liver disease\n* severe inflammation\n* None of the patients are receiving surgical operations or hospitalized in recent 3 months.'}, 'identificationModule': {'nctId': 'NCT06206694', 'briefTitle': 'Serum YKL-40 Levels is Associated With Nutritional and Oxidative Status of Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': "Tungs' Taichung Metroharbour Hospital"}, 'officialTitle': 'Serum YKL-40 Levels is Associated With Nutritional and Oxidative Status of Hemodialysis Patients', 'orgStudyIdInfo': {'id': '112049'}}, 'contactsLocationsModule': {'locations': [{'city': 'Taichung', 'country': 'Taiwan', 'facility': "Tungs' Taichung MetroHarbour Hospital", 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Paik Seong Lim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Tungs' Taichung Metroharbour Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Tungs' Taichung Metroharbour Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}