A Controlled Clinical Trial of Angiotensin-Converting Enzyme Inhibition in Type I Diabetic Nephropathy: Study Design and Patient Characteristics

A placebo-controlled, double-blind clinical trial has been initiated to determine whether angiotensinconverting enzyme inhibitor (ACEI) therapy with captopril (25 mg three times daily) slows the progressive loss of renal function in patients with type I diabetes mellitus. Entry criteria include; (1) ages 18 to 50 yr; (2) onset of insulin-dependent diabetes before the age of 30 yr, insulin dependent for at least 7 yr; (3) 24-h urine protein excretion >500 mg, plus: (a) diabetic retinopathy or (b) if no retinopathy, a renal biopsy diagnosis of diabetic nephropathy; (4) serum