Clinical trial NCT02166359: Effect of Extraneal (Icodextrin) on Triglyceride Levels in PD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: Icodextrin
Triglyceride
Lead sponsor: Dong-A University
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2014-06-18
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The mean difference and change of triglyceride levels after follow up between 2 groups
timeFrame: baseline and 3 months after intervention
Secondary outcomes:
measure: The mean difference and change of erythrocyte membrane monounsaturated fatty acid content and oleic acid content
timeFrame: baseline and 3 months after intervention
measure: The mean difference and change of total cholesterol , LDL, HDL, very low-density lipoprotein, apolipoprotein A and apolipoprotein B
timeFrame: baseline and 3 months after intervention
measure: The mean difference and change of blood glucose level, insulin and HbA1c
timeFrame: baseline and 3 months after intervention
measure: The mean difference and change of ultrafiltration volume
timeFrame: baseline and 3 months after intervention
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
Study officials:
References: