We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00021918
First Posted: August 10, 2001
Last Update Posted: February 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
To examine the independent association of serum total homocysteine and C-reactive protein with arteriosclerotic cardiovascular disease morbidity and mortality.

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

Study Type: Observational
Study Design: Time Perspective: Retrospective

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: April 2001
Study Completion Date: June 2004
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00021918     History of Changes
Other Study ID Numbers: 975
R01HL067695 ( U.S. NIH Grant/Contract )
First Submitted: August 10, 2001
First Posted: August 10, 2001
Last Update Posted: February 18, 2016
Last Verified: October 2005

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Heart Diseases
Atherosclerosis
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases