Serum Total Homocysteine and C-Reactive Protein - Ancillary to IDNT
Serum Total Homocysteine and C-Reactive Protein - Ancillary to IDNT
To examine the independent association of serum total homocysteine and C-reactive protein
 with arteriosclerotic cardiovascular disease morbidity and mortality.
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.
No eligibility criteria