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

End Stage Renal Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02166359
• Other study ID #: EXIT study
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: April 2019

Study information

• Verified date: May 2019
• Source: Dong-A University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• Extraneal (Icodextrin)

• Glucose solution

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University Hospital	Busan

Sponsors (2)

Lead Sponsor	Collaborator
Dong-A University	Baxter Healthcare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The mean difference and change of erythrocyte membrane monounsaturated fatty acid content and oleic acid content		baseline and 3 months after intervention
Secondary	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
Secondary	The mean difference and change of blood glucose level, insulin and HbA1c		baseline and 3 months after intervention
Secondary	The mean difference and change of ultrafiltration volume		baseline and 3 months after intervention