Triglyceride/High-density Lipoprotein Cholesterol Ratio in Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02113462
• Other study ID #: GSM-012014
• Status: Completed
• Phase: N/A
• First received: April 9, 2014
• Last updated: April 10, 2014
• Start date: January 2009
• Est. completion date: January 2013

Study information

• Verified date: April 2014
• Source: Gulhane School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients with chronic kidney disease

Exclusion Criteria:

• taking drugs that may influence endothelial function

• acute infections

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Turkey	Gulhane School of Medicine Department of Endocrinology and Metabolism	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane School of Medicine

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality	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.	30 months	No
Primary	Endothelial functions assessed by flow mediated dilatation and serum ADMA measurement	The predictive role of TG/HDL ratio on endothelial functions (ADMA and flow mediated dilatation) is determined by univariate and multivariate analyses.	Once in recruitment	No