Serum Total Homocysteine and C-Reactive Protein - Ancillary to IDNT
Condition: Cardiovascular Diseases; Atherosclerosis; Heart Diseases; Diabetes Mellitus, Non-insulin Dependent; Hypertension; Diabetes Mellitus
MeSH terms: Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

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

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.
    

Time perspective: Retrospective