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Clinical Study of Serum Fetuin A Level, Insulin Resistance and Hepatic Fat Content in Dialysis Patients

NCT01457625 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2011-10-24

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • National Taiwan University Hospital

    collaborator OTHER

  • Far Eastern Memorial Hospital

    lead OTHER

Principal Investigators

  • Hung-Yuan Chen, MD · Far Eastern Memorial Hospital

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01457625 on ClinicalTrials.gov