Clinical Study of Serum Fetuin A Level, Insulin Resistance and Hepatic Fat Content in Dialysis Patients
The Association of Serum Fetuin A Level, Insulin Resistance and Hepatic Fat Content and Their Associations With Overall Survival in Maintenance Hemodialysis and Peritoneal Dialysis Patients
1 other identifier
observational
300
1 country
2
Brief Summary
Background Fetuin A, synthesized in hepatocyte, is a circulatory inhibitor of precipitation of calcium and phosphate and links to cardiovascular calcification and mortality in dialysis patients; besides, it is associated with insulin resistance in general population. Hepatic fat accumulation enhanced fetuin A secretion in animal model. Objects This study is designed to investigate the association of fetuin A level, insulin resistance and hepatic fat content in dialysis patients. Besides, we planed to observe the survival of dialysis patient with different hepatic fat content. Methods. This is a prospective observational study. Three hundred and fifty ESRD patients undergoing maintenance HD or PD will be recruited for this prospective investigation. All the participants will receive baseline abdominal ultrasound for estimation of hepatic fat content. Hepatic fat content will be estimated as minimal, mild, moderate or severe according to the Hepburn classification. Besides, all participants also check baseline fetuin A, HOMA-IR, hs-CRP, adiponectin, leptin and lipid profiles (T-CHO, TG, LDL-C, HDL-C), nutritional parameter and other biochemical parameters. All participants will be followed for 4 years for survival analysis. The outcomes are all-cause mortality and composite CV mortality. Expected results Dialysis patients with higher hepatic fat may have higher fetuin A levels which may lead to long-term survival benefits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2011
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 20, 2011
CompletedFirst Posted
Study publicly available on registry
October 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedOctober 24, 2011
October 1, 2011
3 years
October 20, 2011
October 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
liver fat contents, fetuin A levels
1 year
Secondary Outcomes (1)
CV and all-cause mortality
4 years
Study Arms (1)
liver fat contents
Eligibility Criteria
Three hundred and fifty ESRD patients undergoing maintenance HD or PD will be recruited for this prospective investigation.
You may qualify if:
- ESRD patients undergoing maintenance HD or PD for more than 6 months
- Age\>20
You may not qualify if:
- Recent hospitalization duet active medical or psychiatric problems
- Active malignancy
- Patient refusal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Far Eastern Memorial Hospitallead
- National Taiwan University Hospitalcollaborator
Study Sites (2)
Far Eastern Memorial Hospital
New Taipei City, Taiwan
Far eastern memorial hospital
New Taipei City, Taiwan
Related Publications (2)
Chen HY, Tsai WC, Chiu YL, Hsu SP, Pai MF, Yang JY, Peng YS. Triglyceride to high-density lipoprotein cholesterol ratio predicts cardiovascular outcomes in prevalent dialysis patients. Medicine (Baltimore). 2015 Mar;94(10):e619. doi: 10.1097/MD.0000000000000619.
PMID: 25761189DERIVEDChen HY, Chiu YL, Chuang YF, Hsu SP, Pai MF, Yang JY, Peng YS. Visceral adiposity index and risks of cardiovascular events and mortality in prevalent hemodialysis patients. Cardiovasc Diabetol. 2014 Oct 4;13:136. doi: 10.1186/s12933-014-0136-5.
PMID: 25280960DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hung-Yuan Chen, MD
Far Eastern Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- attending physician
Study Record Dates
First Submitted
October 20, 2011
First Posted
October 24, 2011
Study Start
January 1, 2011
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
October 24, 2011
Record last verified: 2011-10