A randomized controlled trial to evaluate the effect of glycemic control on renal transplantation outcomes

Context: Outcomes from intensive glycemic control postrenal transplant have not been studied. Objective: Our objective was to observe the optimal management of hyperglycemia in patients with diabetes or impaired glucose tolerance receiving renal transplantation. Design, Setting, and Patients: We conducted a randomized controlled trial with patients undergoing renal transplantation randomized to either iv insulin therapy (intensive) or standard sc insulin therapy while the patients were admitted to the hospital. Interventions: The study consisted of a 3-day postrenal transplant group treated with intensive iv insulin [blood glucose (BG) = 70-110 mg/dl] or a control group treated with sc insulin (BG = 70-180 mg/dl). Main Outcome Measure: The primary endpoint was delayed graft function (DGF). Secondary endpoints were glycemic control, graft survival, and acute rejection episodes. Results: A total of 104 patients were screened and randomized to either the intensive or control condition; however, the intention-to-treat analysis set consisted of only the 93 participants (n = 44 intensive, n = 49 control) that underwent a renal transplant. DGF was present in 18% (eight of 44) of the intensive group and 24% (12 of 49) of the control group (P = 0.46). The occurrence of severe hypoglycemia (BG < 40 mg/dl) and severe hyperglycemia (BG > 350 mg/dl) were the primary safety outcome measures. There were nine participants with hypoglycemia identified, seven of which (78%) were in the intensive treatment group (P = 0.08). There were 30 instances of hyperglycemia with five participants (11%) in the intensive group and 12 participants (24%) in the control group having at least one hyperglycemic event (P = 0.10). For the 11 rejection episodes, nine were in the intensive treatment group (P = 0.013). Conclusions: The primary outcome measure of DGF was not statistically different for the two treatment groups. Regarding longer-term rejection and graft survival, the intensively treated participants were at higher risk for a rejection episode.