This proposal outlines a clinical trial to determine whether angiotensin converting enzyme inhibition therapy alters the rate of loss of renal function and the outcome of patients with type I diabetes mellitus who manifest evidence of diabetic nephropathy. This is one of two grant applications being submitted for this project. This application provides support for the Biostatistical Coordinating Center while the other application (Dr. Edmund J. Lewis, Principal Investigator, Rush- Presbyterian-St. Lukes Medical Center) is for the clinical study. The clinical trial to determine the effect of ACE inhibition therapy is designed to study patients with type I diabetes who have proteinuria of more than 500 mg/24 hrs. and a serum creatinine of less than 2.5 mg/dl. The goal of the study is to determine whether ACE inhibition therapy prevents the progress of type I diabetic glomerulopathy. This clinical trial will involve 20-25 collaborating clinics who will admit 400 patients during a 2 yr. recruitment. The mean follow-up will be 3 yrs. The primary end point is halving of the glomerular filtration rate. The Biostatistical Coordinating Center provides support for these collaborative trials in the study design (procedures, forms randomization), execution (data processing support, editing, updating corrections, monitoring performance of clinics, patient safety data monitoring) and final statistical analysis and publications.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project (R01)
Project #
5R01DK039826-02
Application #
3239835
Study Section
Diabetes and Digestive and Kidney Diseases Special Grants Review Committee (DDK)
Project Start
1987-09-30
Project End
1992-08-31
Budget Start
1988-09-01
Budget End
1989-08-31
Support Year
2
Fiscal Year
1988
Total Cost
Indirect Cost
Name
George Washington University
Department
Type
Schools of Arts and Sciences
DUNS #
City
Washington
State
DC
Country
United States
Zip Code
20052
Rodby, R A; Rohde, R D; Sharon, Z et al. (1995) The urine protein to creatinine ratio as a predictor of 24-hour urine protein excretion in type 1 diabetic patients with nephropathy. The Collaborative Study Group. Am J Kidney Dis 26:904-9
Breyer, J A; Hunsicker, L G; Bain, R P et al. (1994) Angiotensin converting enzyme inhibition in diabetic nephropathy. The Collaborative Study Group. Kidney Int Suppl 45:S156-60
Lewis, E J; Hunsicker, L G; Bain, R P et al. (1993) The effect of angiotensin-converting-enzyme inhibition on diabetic nephropathy. The Collaborative Study Group. N Engl J Med 329:1456-62
Lan, K K; Lachin, J M (1990) Implementation of group sequential logrank tests in a maximum duration trial. Biometrics 46:759-70
Lachin, J M (1988) Properties of simple randomization in clinical trials. Control Clin Trials 9:312-26
Lachin, J M (1988) Statistical properties of randomization in clinical trials. Control Clin Trials 9:289-311
Lachin, J M; Matts, J P; Wei, L J (1988) Randomization in clinical trials: conclusions and recommendations. Control Clin Trials 9:365-74