Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT00021918
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2001-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Serum Total Homocysteine and C-Reactive Protein - Ancillary to IDNT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-10', 'completionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-17', 'studyFirstSubmitDate': '2001-08-10', 'studyFirstSubmitQcDate': '2001-08-09', 'lastUpdatePostDateStruct': {'date': '2016-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-10', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases', 'Atherosclerosis', 'Heart Diseases', 'Diabetes Mellitus, Non-insulin Dependent', 'Hypertension', 'Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '14709365', 'type': 'BACKGROUND', 'citation': 'Friedman AN, Hunsicker LG, Selhub J, Bostom AG. Clinical and nutritional correlates of C-reactive protein in type 2 diabetic nephropathy. Atherosclerosis. 2004 Jan;172(1):121-5. doi: 10.1016/j.atherosclerosis.2003.09.011.'}, {'pmid': '16162814', 'type': 'BACKGROUND', 'citation': 'Friedman AN, Hunsicker LG, Selhub J, Bostom AG; Collaborative Study Group. Total plasma homocysteine and arteriosclerotic outcomes in type 2 diabetes with nephropathy. J Am Soc Nephrol. 2005 Nov;16(11):3397-402. doi: 10.1681/ASN.2004100846. Epub 2005 Sep 14.'}, {'pmid': '16014055', 'type': 'BACKGROUND', 'citation': 'Friedman AN, Hunsicker LG, Selhub J, Bostom AG; Collaborative Study Group. C-reactive protein as a predictor of total arteriosclerotic outcomes in type 2 diabetic nephropathy. Kidney Int. 2005 Aug;68(2):773-8. doi: 10.1111/j.1523-1755.2005.00456.x.'}]}, 'descriptionModule': {'briefSummary': 'To examine the independent association of serum total homocysteine and C-reactive protein with arteriosclerotic cardiovascular disease morbidity and mortality.', 'detailedDescription': 'BACKGROUND:\n\nPatients with diabetic nephropathy experience markedly increased rates of morbidity and mortality due to arteriosclerotic cardiovascular disease \\[CVD\\]. Established arteriosclerotic risk factors such as age, sex, cigarette smoking, hypertension, and dyslipidemia do not account adequately for this excess CVD risk. Prospective data from general populations, and much more limited findings from both diabetic cohorts. and cohorts with chronic renal disease, have linked elevated levels of total homocysteine (tHcy) and C-reactive protein (CRP) to arteriosclerotic CVD morbidity and mortality. Determination of baseline serum total homocysteine and C-reactive protein concentrations in the Irbesartan Type 2 Diabetic Nephropathy Trial (IDNT) cohort affords a truly unique opportunity to evaluate the potential independent relationship between these putative CVD risk factors and subsequent CVD morbidity and mortality, in this patient population. The IDNT is a multicenter, randomized, double-blind, placebo-controlled trial of 1,715 hypertensive, Type 2 diabetic patients aged 30 to 70 who have overt nephropathy (24 hour urinary protein excretion greater than 900 mg and a serum creatinine of 90 to 265 micromols/L). The IDNT compares the effect of the angiotensin II receptor antagonist irbesartan with placebo and amlodipine on the progression of renal disease and mortality. The IDNT is supported by Bristol-Myers Squibb Company in Princeton, New Jersey and Sanofi-Synthelabo in Paris, France.\n\nThe study is in response to an initiative "Ancillary Studies in Heart, Lung, and Blood Disease Trials" released by the National Heart, Lung, and Blood Institute in June 2000.\n\nDESIGN NARRATIVE:\n\nThe first specific aim is to conduct longitudinal analyses of the potential "Independent" relationship between baseline concentrations of serum total homocysteine and C-reactive protein in the full IDNT cohort, and subsequent:pooled cardiovascular disease morbidity and mortality (primary analysis). total mortality, (after multivariable -adjustment for the established predictors of cardiovascular disease morbidity/ mortality, and total mortality). The second specific aim is to conduct cross-sectional analyses to assess baseline serum total homocysteine and C-reactive protein concentrations in the full IDNT cohort, in relation to potential baseline determinants of these analytes, including: B-vitamin status; age and gender; renal function indices, i.e. both creatinine-based glomerular filtration rate estimates, and proteinuria; indices of glycemia, prevalent cardiovascular disease (CVD), traditional CVD risk factors (i.e., in particular, smoking, blood pressure, and total cholesterol/HDL cholesterol ratio).\n\nThe study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'No eligibility criteria'}, 'identificationModule': {'nctId': 'NCT00021918', 'briefTitle': 'Serum Total Homocysteine and C-Reactive Protein - Ancillary to IDNT', 'organization': {'class': 'NIH', 'fullName': 'National Heart, Lung, and Blood Institute (NHLBI)'}, 'orgStudyIdInfo': {'id': '975'}, 'secondaryIdInfos': [{'id': 'R01HL067695', 'link': 'https://reporter.nih.gov/quickSearch/R01HL067695', 'type': 'NIH'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Andrew Bostom', 'affiliation': 'Memorial hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}}}}