Effect of Extraneal (Icodextrin) on Triglyceride Levels in PD Patients
Status:
Completed
Trial end date:
2019-04-01
Target enrollment:
Participant gender:
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.