This is one of two applications submitted for the proposed clinical trial. This application proposes support for the Clinical Coordinating Center of the Lupus Nephritis Collaborative Study Group and the collaborating clinics. A separate application proposes support of the Biostatistical-Coordinating Center (John M. Lachin, Sc.D., Principal Investigator). The clinical trial to determine the effects of ACE inhibitor therapy is based upon experimental studies which indicate that this pharmacologic intervention can prevent glomerular injury in the diabetic state. The trial is designed to study patients with Type I diabetes who have proteinuria of more than 500mg/24hrs and a serum creatinine of less than 2.5mg/dl. Because the primary purpose of the study is to determine whether the intrarenal effects of the ACE inhibitor, captopril alters the expected progressive decline in renal function, blood pressure will be carefully controlled in both the experimental and placebo groups. 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 as defined by doubling of the serum creatinine to at least 2mg/dl. The primary goals of the Study are to determine whether ACE inhibitor therapy prevents the progress of Type I diabetic glomerulopathy with respect to significantly decreased: a) rate of loss of GFR b) urine protein excretion rate c) end stage renal failure rate d) mortality rate. The secondary goals of the Study are to 1) follow the """"""""natural history"""""""" of a large group of patients with glomerulopathy associated with Type I diabetes mellitus who are managed by controlling their systemic hypertension but have not received ACE inhibitor or calcium channel blocking agents. 2) provide for the controlled evaluation and assessment of progressive retinopathy in a large group of Type I diabetic patients whose systemic hypertension is very closely controlled.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project (R01)
Project #
5R01DK039908-02
Application #
3239951
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
Rush University Medical Center
Department
Type
DUNS #
City
Chicago
State
IL
Country
United States
Zip Code
60612
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
Rodby, R A; Ali, A; Rohde, R D et al. (1992) Renal scanning 99mTc diethylene-triamine pentaacetic acid glomerular filtration rate (GFR) determination compared with iothalamate clearance GFR in diabetics. The Collaborative Study Group for The study of Angiotensin-Converting Enzyme Inhibition in Diabe Am J Kidney Dis 20:569-73
Bain, R; Rohde, R; Hunsicker, L G et al. (1992) A controlled clinical trial of angiotensin-converting enzyme inhibition in type I diabetic nephropathy: study design and patient characteristics. The Collaborative Study Group. J Am Soc Nephrol 3:S97-103
Lemann, J; Bidani, A K; Bain, R P et al. (1990) Use of the serum creatinine to estimate glomerular filtration rate in health and early diabetic nephropathy. Collaborative Study Group of Angiotensin Converting Enzyme Inhibition in Diabetic Nephropathy. Am J Kidney Dis 16:236-43
Sasse, E A; Doumas, B T; Lemann Jr, J (1989) Diabetic nephropathy: urinary albumin or total protein? Ann Intern Med 111:343-4