NCT02113462

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
Last Updated

April 14, 2014

Status Verified

April 1, 2014

Enrollment Period

4 years

First QC Date

April 9, 2014

Last Update Submit

April 10, 2014

Conditions

Chronic Kidney Disease

Keywords

Chronic kidney diseaseEndothelial dysfunctionInflammationInsulin resistanceTg/hdl ratio

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

renal unit

You may qualify if:

  • patients with chronic kidney disease

You may not qualify if:

  • taking drugs that may influence endothelial function
  • acute infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane School of Medicine Department of Endocrinology and Metabolism

Ankara, Ankara, 06018, Turkey (Türkiye)

Location

Related Publications (1)

  • Sonmez A, Yilmaz MI, Saglam M, Unal HU, Gok M, Cetinkaya H, Karaman M, Haymana C, Eyileten T, Oguz Y, Vural A, Rizzo M, Toth PP. The role of plasma triglyceride/high-density lipoprotein cholesterol ratio to predict cardiovascular outcomes in chronic kidney disease. Lipids Health Dis. 2015 Apr 16;14:29. doi: 10.1186/s12944-015-0031-4.

    PMID: 25885289DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicInflammationInsulin Resistance

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Medicine

Study Record Dates

First Submitted

April 9, 2014

First Posted

April 14, 2014

Study Start

January 1, 2009

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

April 14, 2014

Record last verified: 2014-04

Locations

TU(1)