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

NCT ID: NCT02166359

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2019-04-30

Brief 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

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Glucose group

Glucose use of 2.5% or 4.25% dextrose solution at least 4 hours

Group Type: ACTIVE_COMPARATOR

Glucose solution

Intervention Type: DRUG

Extraneal (Icodextrin) group

Extraneal (Icodextrin) use at least 8 hours

Group Type: EXPERIMENTAL

Extraneal (Icodextrin)

Intervention Type: DRUG

Interventions

Extraneal (Icodextrin)

Intervention Type: DRUG

Glucose solution

Intervention Type: DRUG

Other Intervention Names

Extraneal; Icodextrin; 2.5% dextrose solution; 4.25% dextrose solution

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

Dong-A University

OTHER

Sponsor Role: lead

Responsible Party

WON SUK AN

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dong-A University Hospital

Busan, , South Korea

Countries

South Korea

Other Identifiers

EXIT study

Identifier Type: -

Identifier Source: org_study_id