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Serum Total Homocysteine and C-Reactive Protein - Ancillary to IDNT

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ClinicalTrials.gov Identifier: NCT00021918
Recruitment Status : Completed
First Posted : August 10, 2001
Last Update Posted : February 18, 2016
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
To examine the independent association of serum total homocysteine and C-reactive protein with arteriosclerotic cardiovascular disease morbidity and mortality.

Condition or disease
Cardiovascular Diseases Atherosclerosis Heart Diseases Diabetes Mellitus, Non-insulin Dependent Hypertension Diabetes Mellitus

Detailed Description:

BACKGROUND:

Patients 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.

The 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.

DESIGN NARRATIVE:

The 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).

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.


Study Type : Observational
Time Perspective: Retrospective
Study Start Date : April 2001
Actual Study Completion Date : June 2004




Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00021918


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Andrew Bostom Memorial hospital