The Minnesota diabetes complications clinical trial. The first three years.

A prospective and randomized clinical trial of an inception cohort of diabetic kidney recipients to test the hypothesis that maximized metabolic control of diabetes prevents or delays diabetic nephropathy in the renal allografts was initiated approximately three years ago. Notwithstanding the fact that all our diabetic patients were on prednisone and therefore metabolically unstable, we achieved and maintained a clear difference between the standard control (group A) and the maximized control patients (group B). At 13 months of study, the mean fasting blood glucose mg% (A: 242 +/- 22, B: 130 +/- 9, p less than 0.001), nonfasting blood glucose (A: 276 +/- 40, B: 135 +/- 10, p less than 0.001), 24 hour urine glucose (A: 85 +/- 16, B: 5 +/- 1, p less than 0.001), and glycosylated hemoglobin % (A: 13 +/- 0.9, B: 10 +/- 0.8, p less than 0.01) were all clearly and statistically significantly higher for the group A patients. These results show the feasibility of such a trial using the tools available today to treat diabetes.