| Trial ID: | L0880 |
| Source ID: | NCT02166359
|
| Associated Drug: |
Extraneal (Icodextrin)
|
| Title: |
Effect of Extraneal (Icodextrin) on Triglyceride Levels in PD Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Disease
|
| Interventions: |
DRUG: Extraneal (Icodextrin)|DRUG: Glucose solution
|
| Outcome Measures: |
Primary: 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: 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
|
| Sponsor/Collaborators: |
Sponsor: Dong-A University | Collaborators: Baxter Healthcare Corporation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
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| Phases: |
|
| Enrollment: |
22
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2014-06
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| Completion Date: |
2019-04
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| Results First Posted: |
|
| Last Update Posted: |
2019-05-29
|
| Locations: |
Dong-A University Hospital, Busan, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT02166359
|