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Effect of Extraneal (Icodextrin) on Triglyceride Levels in PD Patients

NCT02166359 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-05-29

No results posted yet for this study

Summary

Patients with chronic kidney disease (CKD) have a markedly higher prevalence of cardiovascular disease (CVD) than the general population. Dyslipidemia is considered a major cause of CVD in patients with CKD. Especially for peritoneal dialysis (PD) patients, the use of glucose as the osmotic agent in PD solutions has been associated with a variety of metabolic consequences ranging from acute hyperglycemia and hyperinsulinemia to dyslipidemia and weight gain. Among lipid abnormalities, hypertriglyceridemia is the most common in PD patients. A study showed that patients with high triglyceride levels were more insulin-resistant than those with normal triglyceride levels.

Insulin resistant is associated with atherogenic response represented high plasma levels of monocyte chemotactic protein-1 in a large cohort of dialysis patients. Therefore, high triglyceride level may play an important role to CV outcome of PD patients. PD solution decreasing triglyceride levels is essential in PD patients.

Icodextrin, a starch-derived high molecular weight glucose polymer was found to increase ultrafiltration compared to glucose solutions. Furthermore, a low peritoneal absorption of icodextrin, which is catabolized into maltose, considerably reduces caloric uptake. Therefore, icodextrin may have an additional favorable effect on triglyceride level.

There are several studies regarding the effect of icodextrin on triglyceride level in PD patients. However, the outcomes are controversial, some studies showed no association between icodextrin and triglyceride change, even the others showed positive results but these also have study design limitations such as non-randomized study or secondary primary outcome. It is not clear about the effect of icodextrin on triglyceride especially in PD patients without diabetes.

The investigators therefore want to conduct a randomized, cross-over, controlled multicenter trial comparing icodextrin solution and glucose solution in PD patients with and without diabetes, focusing on triglyceride change.

Conditions

Interventions

DRUG

Extraneal (Icodextrin)

DRUG

Glucose solution

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Dong-A University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2019-03-31
Completion
2019-04-30

Countries

  • South Korea

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 NCT02166359 on ClinicalTrials.gov