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

NCT02166359 | Completed

• 1 other identifier: EXIT study
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Keywords

Icodextrin; Triglyceride

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Glucose group

ACTIVE COMPARATOR

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

Drug: Glucose solution

Extraneal (Icodextrin) group

EXPERIMENTAL

Extraneal (Icodextrin) use at least 8 hours

Drug: Extraneal (Icodextrin)

Interventions

Extraneal (Icodextrin) DRUG

Also known as: Extraneal, Icodextrin

Extraneal (Icodextrin) group

Glucose solution DRUG

Also known as: 2.5% dextrose solution, 4.25% dextrose solution

Glucose group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A University: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Dong-A University Hospital

Busan, South Korea

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Icodextrin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 14, 2014
• First Posted: June 18, 2014
• Study Start: June 1, 2014
• Primary Completion: March 1, 2019
• Study Completion: April 1, 2019
• Last Updated: May 29, 2019

Record last verified: 2019-05

Locations

KR (1)