Serum YKL-40 Levels is Associated With Nutritional and Oxidative Status of Hemodialysis Patients

NCT06206694 | Completed

• 1 other identifier: 112049
• Study Type: observational
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

Background YKL-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 Methods We 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.

Conditions

Malnutrition; Oxidative Stress

Keywords

YKL-40; nutrition status; hemodialysis patients; inflammation

Outcome Measures

Primary Outcomes (2)

• Analysis of biomarkers of YKL40

  YKL40 is also reportedly useful as an inflammation marker in HD patients

  1 years

• Evaluation of nutritional status and body composition

  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.

  1 years

Secondary Outcomes (7)

• Analysis of biomarkers of IL-6

  1 years

• vaspin

  1 years

• insulin

  1 years

• adiponectin

  1 years

• total antioxidant capacity

  1 years

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients have to be at least 20-years-old and hemodialysis (HD) for at least 3 months.

You may qualify if:

• Both sexes aged 20 years or over
• Received stable hemodialysis at least 3 months.
• Written informed consent.

You may not qualify if:

• heart failure
• infection
• cirrhosis
• respiratory disease
• nephrotic syndrome
• malignancy
• chronic liver disease
• severe inflammation
• None of the patients are receiving surgical operations or hospitalized in recent 3 months.

Sponsors & Collaborators

• Tungs' Taichung Metroharbour Hospital: lead

Study Sites (1)

Tungs' Taichung MetroHarbour Hospital

Taichung, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Malnutrition; Inflammation

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paik Seong Lim, PhD

  Tungs' Taichung Metroharbour Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: May 2, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

TW (1)