Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2026-03-10 @ 8:06 PM
Study NCT ID:
NCT01792206
Status:
UNKNOWN
Last Update Posted:
2013-02-15
First Post:
2012-02-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect Of Paricalcitol (Zemplar) On Endothelial Function And Inflammation In Type 2 Diabetes And Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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': 'C084656', 'term': 'paricalcitol'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-02-12', 'studyFirstSubmitDate': '2012-02-29', 'studyFirstSubmitQcDate': '2013-02-12', 'lastUpdatePostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in brachial artery Flow Mediated Dilataion with paracalcitol (1mcg/day)compared with placebo for 3 months.', 'timeFrame': 'Baseline, 4 weeks, and 12 weeks', 'description': 'We therefore propose a study of the effects of Zemplar compared to placebo in patients with diabetes and stage 3-4 CKD on endothelial function and markers of inflammation and oxidative stress. The finding will help not only guide and encourage such treatment in similar patients, but will give us fundamental mechanistic insights into the role of vitamin D in the pathogenesis of diabetes and CVD.'}], 'secondaryOutcomes': [{'measure': 'Biomarker Measurement', 'timeFrame': 'Baseline, 4 weeks, and 12 weeks', 'description': 'Determine the prevalance of abnormalities in biomarkers of inflammation, oxidative stress and endothelial function in patients with CKD compared to a healthy population\n\nThe following are the biomarkers of inflammation and oxidative stress to be measured in the secondary outcomes are:\n\nNFkB binding by mononuclear cells (MNC) ; ROS generation and p47phox expression by MNC plasma concentration of MMP-9, MCP-1, ICAM-1, IL-6 , CRP, ADMA and nitrotyrosine.. urinary isoprostane and plasma Nitrotyrosine in patients with CKD.'}, {'measure': 'Biomarker Measurement', 'timeFrame': 'Baseline, 4 weeks, and 12 weeks', 'description': 'Compare the change in biomarkers of inflammation, oxidative stress and endothelial function with paracalcitol (1mcg/day) compared with placebo for 3 months in patients with CKD.\n\nThe following are the biomarkers of inflammation and oxidative stress to be measured in the secondary outcomes are:\n\nNFkB binding by mononuclear cells (MNC) ; ROS generation and p47phox expression by MNC plasma concentration of MMP-9, MCP-1, ICAM-1, IL-6 , CRP, ADMA and nitrotyrosine.. urinary isoprostane and plasma Nitrotyrosine in patients with CKD.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stage 3 chronic kidney disease (CKD)', 'Stage 4 chronic kidney disease (CKD)', 'CKD'], 'conditions': ['Type 2 Diabetes', 'Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to study the effects of paricalcitol on endothelial function and inflammation, cardiovascular risk factors which are associated with patient populations that have Type 2 diabetes and Stage 3 and 4 Chronic Kidney Disease (CKD).\n\nHypothesis 1: The state of CKD is associated with oxidative stress and inflammation and impaired post ischemic endothelium dependent flow mediated vasodilation which may contribute to atherogenesis.\n\nHypothesis 2: The administration of paracalcitol to patients with CKD will suppress oxidative stress and inflammation and improve endothelial function and thus contribute to an anti-atherogenic action.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with Type 2 diabetes and CKD\n2. Age 18 - 70 years\n3. Stable anti-hypertensive and lipid lowering therapy for at least 2 months. All patients should be on an ACEI or ARB unless contraindicated because of side effects (standard of care). No changes in lipid lowering therapy during the 3 months of this study. Blood pressure doses may be changed but new therapy with ACE inhibitors will not be allowed.\n\nExclusion Criteria:\n\n1. Severe co morbid conditions - e.g. Cancer, etc.\n2. Congestive heart failure.\n3. Inability to give informed consent or attend study related visits.\n4. Have a history of abnormally high vitamin D or calcium levels in the bloodstream.\n5. Unwilling or unable to complete screening or data collection procedures.\n6. Have a known allergy to the study drug.\n7. Pregnant or breast feeding\n8. Plasma Calcium \\>9 mg/dl\n9. Patients should discontinue any calcium supplementation prior to entry into the study.\n10. Other vitamin D analogs (eg Sensipar) and vitamin D preparations are contraindicated'}, 'identificationModule': {'nctId': 'NCT01792206', 'briefTitle': 'Effect Of Paricalcitol (Zemplar) On Endothelial Function And Inflammation In Type 2 Diabetes And Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Scott and White Hospital & Clinic'}, 'officialTitle': 'EFFECT OF PARICALCITOL (ZEMPLAR) ON ENDOTHELIAL FUNCTION AND INFLAMMATION IN TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE', 'orgStudyIdInfo': {'id': '81890'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Zemplar', 'description': 'Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months', 'interventionNames': ['Drug: Zemplar']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Zemplar', 'type': 'DRUG', 'description': 'Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months', 'armGroupLabels': ['Zemplar']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Joslin Diabetes Clinic, Inc.', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '68105', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Omaha VA Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scott and White Hospital & Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, CArdioMEtabolic, Lipid Clinic and Medical Weight Management Program Services', 'investigatorFullName': 'Vasudevan Raghavan', 'investigatorAffiliation': 'Scott and White Hospital & Clinic'}}}}