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

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Extraneal (Icodextrin)
Glucose solution
Sponsored by
Dong-A University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Icodextrin, Triglyceride

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dong-A University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Glucose group

Extraneal (Icodextrin) group

Arm Description

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

Extraneal (Icodextrin) use at least 8 hours

Outcomes

Primary Outcome Measures

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) )

Secondary Outcome Measures

The mean difference and change of erythrocyte membrane monounsaturated fatty acid content and oleic acid content
The mean difference and change of total cholesterol , LDL, HDL, very low-density lipoprotein, apolipoprotein A and apolipoprotein B
The mean difference and change of blood glucose level, insulin and HbA1c
The mean difference and change of ultrafiltration volume

Full Information

First Posted
June 14, 2014
Last Updated
May 27, 2019
Sponsor
Dong-A University
Collaborators
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02166359
Brief Title
Effect of Extraneal (Icodextrin) on Triglyceride Levels in PD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dong-A University
Collaborators
Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
Icodextrin, Triglyceride

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucose group
Arm Type
Active Comparator
Arm Description
Glucose use of 2.5% or 4.25% dextrose solution at least 4 hours
Arm Title
Extraneal (Icodextrin) group
Arm Type
Experimental
Arm Description
Extraneal (Icodextrin) use at least 8 hours
Intervention Type
Drug
Intervention Name(s)
Extraneal (Icodextrin)
Other Intervention Name(s)
Extraneal, Icodextrin
Intervention Type
Drug
Intervention Name(s)
Glucose solution
Other Intervention Name(s)
2.5% dextrose solution, 4.25% dextrose solution
Primary Outcome Measure Information:
Title
The mean difference and change of triglyceride levels after follow up between 2 groups
Description
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) )
Time Frame
baseline and 3 months after intervention
Secondary Outcome Measure Information:
Title
The mean difference and change of erythrocyte membrane monounsaturated fatty acid content and oleic acid content
Time Frame
baseline and 3 months after intervention
Title
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
Title
The mean difference and change of blood glucose level, insulin and HbA1c
Time Frame
baseline and 3 months after intervention
Title
The mean difference and change of ultrafiltration volume
Time Frame
baseline and 3 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Dong-A University Hospital
City
Busan
Country
Korea, Republic of

12. IPD Sharing Statement

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

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