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NCT Number: NCT02166359

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

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.

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dong-A University Hospital

Busan, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extraneal (Icodextrin)

Drug

Other names: Extraneal, Icodextrin

Glucose solution

Drug

Other names: 2.5% dextrose solution, 4.25% dextrose solution

Primary outcomes

  1. The mean difference and change of triglyceride levels after follow up between 2 groups

    Time frame: baseline and 3 months after intervention

    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) )

Secondary outcomes

  1. The mean difference and change of erythrocyte membrane monounsaturated fatty acid content and oleic acid content

    Time frame: baseline and 3 months after intervention

  2. The mean difference and change of total cholesterol , LDL, HDL, very low-density lipoprotein, apolipoprotein A and apolipoprotein B

    Time frame: baseline and 3 months after intervention

  3. The mean difference and change of blood glucose level, insulin and HbA1c

    Time frame: baseline and 3 months after intervention

  4. The mean difference and change of ultrafiltration volume

    Time frame: baseline and 3 months after intervention

Sponsors and collaborators

Lead sponsor

Dong-A University

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jun 18, 2014
Registry last updated
May 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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