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Clinical Trials/NCT02113462
NCT02113462CompletedNot Applicable

The Prospective Cohort Study to Investigate the Role of Plasma Triglyceride/High-Density Lipoprotein Cholesterol Ratio To Predict Cardiovascular Outcomes in Chronic Kidney Disease.

Gulhane School of Medicine1 site in 1 country197 target enrollmentStarted: January 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
197
Locations
1
Primary Endpoint
All cause mortality

Study Overview

Brief Summary

The Triglycerides (TG) to High Density Lipoprotein Cholesterol (HDL-C) ratio is a feature of insulin resistance and an independent predictor of cardiovascular risk. The investigators aimed to evaluate the relationship between TG/HDL-C ratio and the endothelial functions in patients with CKD.

Detailed Description

Cardiovascular disease (CVD) risk is substantially increased in subjects with chronic kidney disease (CKD).The reasons for the elevated risk of CVD in patients with CKD are not fully elucidated. There is not a good prognostic tool for the prediction of increased cardiovascular risk in CKD. A simple, widely available, relatively inexpensive, and generally reproducible marker to predict the CVD risk in subjects with CKD is needed.

The Triglycerides (TG) to High Density Lipoprotein Cholesterol (HDL-C) ratio is a feature of insulin resistance and an independent predictor of cardiovascular risk. No study has been performed so far, to evaluate the role of TG/HDL ratio to predict the CVD risk in patients with CKD.

This study is designed to evaluate the relationship between TG/HDL-C ratio and the endothelial functions in patients with CKD.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • patients with chronic kidney disease

Exclusion Criteria

  • taking drugs that may influence endothelial function
  • acute infections

Outcomes

Primary Outcomes

All cause mortality

Time Frame: 30 months

The COX analysis was performed in order to establish which covariates were independent predictors of cardiovascular outcomes. Kaplan Meier survival curves are generated to show the impact of the TG/HDL ratio on the cumulative survival of the cohort. The predictive power of the median TG/HDL ratio in each CKD stage for all-cause mortality and cardiovascular events are measured.

Endothelial functions assessed by flow mediated dilatation and serum ADMA measurement

Time Frame: Once in recruitment

The predictive role of TG/HDL ratio on endothelial functions (ADMA and flow mediated dilatation) is determined by univariate and multivariate analyses.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Gulhane School of Medicine
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alper Sonmez

Associate Professor in Medicine

Gulhane School of Medicine

Study Sites (1)

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