Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-27 @ 5:21 AM
Study NCT ID:
NCT02166359
Status:
COMPLETED
Last Update Posted:
2019-05-29
First Post:
2014-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Extraneal (Icodextrin) on Triglyceride Levels in PD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077607', 'term': 'Icodextrin'}], 'ancestors': [{'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-27', 'studyFirstSubmitDate': '2014-06-14', 'studyFirstSubmitQcDate': '2014-06-17', 'lastUpdatePostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The mean difference and change of triglyceride levels after follow up between 2 groups', 'timeFrame': 'baseline and 3 months after intervention', '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) )'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Icodextrin', 'Triglyceride'], 'conditions': ['End Stage Renal Disease']}, 'descriptionModule': {'briefSummary': '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.\n\nInsulin 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.\n\nIcodextrin, 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.\n\nThere 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PD patients agree with written informed consent\n* Incident and prevalent PD patients on dialysis for at least 3month\n* PD patients treated with two glucose solutions including 2.5% or 4.25% dextrose solution at least 4hour\n\nExclusion Criteria:\n\n* PD patients with allergy to starch-based polymers\n* PD patients with glycogen storage disease\n* PD patients with maltose or isomaltose intolerance\n* PD patients with active alcohol/substance abuse\n* Pregnant or nursing PD patients\n* PD patients with an episode of peritonitis and active systemic infection within 4weeks before study initiation\n* PD patients newly prescribed with lipid-lowering medications, including statins, omega-3 fatty acids or sevelamer hydrochloride within 3 months before randomization\n* PD patients with triglyceride level\\> 500 mg/dL/L or \\<100 mg/dL\n* PD patients with albumin level \\< 3.0 gram/dL\n* PD patients treated with automated PD\n* PD patients had been treated or are treating with icodextrin PD solutions'}, 'identificationModule': {'nctId': 'NCT02166359', 'briefTitle': 'Effect of Extraneal (Icodextrin) on Triglyceride Levels in PD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Dong-A University'}, 'orgStudyIdInfo': {'id': 'EXIT study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Glucose group', 'description': 'Glucose use of 2.5% or 4.25% dextrose solution at least 4 hours', 'interventionNames': ['Drug: Glucose solution']}, {'type': 'EXPERIMENTAL', 'label': 'Extraneal (Icodextrin) group', 'description': 'Extraneal (Icodextrin) use at least 8 hours', 'interventionNames': ['Drug: Extraneal (Icodextrin)']}], 'interventions': [{'name': 'Extraneal (Icodextrin)', 'type': 'DRUG', 'otherNames': ['Extraneal', 'Icodextrin'], 'armGroupLabels': ['Extraneal (Icodextrin) group']}, {'name': 'Glucose solution', 'type': 'DRUG', 'otherNames': ['2.5% dextrose solution', '4.25% dextrose solution'], 'armGroupLabels': ['Glucose group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Busan', 'country': 'South Korea', 'facility': 'Dong-A University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'WON SUK AN', 'investigatorAffiliation': 'Dong-A University'}}}}