Effects of pulsatile intravenous insulin therapy on the progression of diabetic nephropathy

The purpose of this study was to assess the effects of pulsatile intravenou s insulin therapy (PIVIT) on the progression of diabetic nephropathy in pat ients with type 1 diabetes mellitus (DM). This 18-month multicenter, prospe ctive, controlled study involved 49 type 1 DM patients with nephropathy who were following the Diabetes Control and Complications Trial (DCCT) intensi ve therapy (IT) regimen. Of these, 26 patients formed the control group (C) , which continued on IT, while 23 patients formed the treatment group (T) a nd underwent, in addition to IT, weekly PIVIT. Blood pressure in all patien ts was maintained below 140/90 mm Hg on antihypertensive medication, prefer entially using angiotensin-converting enzyme (ACE) inhibitors. Ail study pa tients were seen in the clinic weekly for 18 months, had monthly glycohemog lobin (HbA(1c)), and every 3 months, 24-hour urinary protein excretion and creatinine clearance (CrCl) determinations. The HbA(1c) levels declined fro m 8.61% +/- 0.33% to 7.68% +/- 0.31% (P = .0028) in the T group and from 9. 13% +/- 0.36% to 8.19% +/- 0.33% (P = .0015) in the C group during the stud y period. CrCl declined significantly in both groups, as expected, but the rate of CrCl decline in the T group (2.21 +/- 1.62 ml/min/yr) was significa ntly less than in the C group (7.69 +/- 1.88 ml/min/yr, P = .0343). We conc lude that when PIVIT is added to IT in type 1 DM patients with overt nephro pathy, it appears to markedly reduce the progression of diabetic nephropath y. The effect appears independent of ACE inhibitor therapy, blood pressure, or glycemic control. Copyright (C) 2000 by W.B. Saunders Company.