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

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Drug: Glucose solution; Drug: Extraneal (Icodextrin)

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Dong-A University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• PD patients agree with written informed consent
• Incident and prevalent PD patients on dialysis for at least 3month
• PD patients treated with two glucose solutions including 2.5% or 4.25% dextrose solution at least 4hour

Exclusion Criteria:

• PD patients with allergy to starch-based polymers
• PD patients with glycogen storage disease
• PD patients with maltose or isomaltose intolerance
• PD patients with active alcohol/substance abuse
• Pregnant or nursing PD patients
• PD patients with an episode of peritonitis and active systemic infection within 4weeks before study initiation
• PD patients newly prescribed with lipid-lowering medications, including statins, omega-3 fatty acids or sevelamer hydrochloride within 3 months before randomization
• PD patients with triglyceride level> 500 mg/dL/L or <100 mg/dL
• PD patients with albumin level < 3.0 gram/dL
• PD patients treated with automated PD
• PD patients had been treated or are treating with icodextrin PD solutions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Glucose group; Glucose use of 2.5% or 4.25% dextrose solution at least 4 hours	Drug: Glucose solution; Other Names: 2.5% dextrose solution; 4.25% dextrose solution
Experimental: Extraneal (Icodextrin) group; Extraneal (Icodextrin) use at least 8 hours	Drug: Extraneal (Icodextrin); Other Names: Extraneal; Icodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The mean difference and change of triglyceride levels after follow up between 2 groups	The difference and change of triglyceride after follow up between 2 groups (glucose group with diabetes (n=20) vs. icodextrin group with diabetes (n=20) and glucose group without diabetes (n=20) vs. icodextrin group without diabetes (n=20) )	baseline and 3 months after intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
The mean difference and change of erythrocyte membrane monounsaturated fatty acid content and oleic acid content	baseline and 3 months after intervention
The mean difference and change of total cholesterol , LDL, HDL, very low-density lipoprotein, apolipoprotein A and apolipoprotein B	baseline and 3 months after intervention
The mean difference and change of blood glucose level, insulin and HbA1c	baseline and 3 months after intervention
The mean difference and change of ultrafiltration volume	baseline and 3 months after intervention

Collaborators and Investigators

• Sponsor: Dong-A University
• Collaborators: Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: June 14, 2014
• First Submitted That Met QC Criteria: June 17, 2014
• First Posted (Estimate): June 18, 2014

Study Record Updates

• Last Update Posted (Actual): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 27, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Icodextrin; Triglyceride
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Dialysis Solutions; Pharmaceutical Solutions; Icodextrin
• Other Study ID Numbers: EXIT study