Concerns in Planning Studies of Diabetic Nephropathy

  • Eli A. Friedman
Part of the Topics in Renal Medicine book series (TIRM, volume 6)


It is safe to predict that the clinical approach to diabetic nephropathy will undergo great change during the 13 years remaining in this century. Trials are now in progress to assess which key strategic therapeutic maneuvers (table 47-1) will become conventional therapy before this decade ends. Unless an effect is strikingly evident—insulin administration to a diabetic in coma, for example—the means chosen for validating a new treatment are crucial to the avoidance of confusion between hope and reality. By way of illustration, consider that, more than a half-century after the introduction of a low-protein diet in renal insufficiency, there is persistent disagreement as to its value [1, 2]. Because of this controversy, a multicenter trial of protein restriction in “mild” renal disease is now beginning in the United States, the results of which may not be evident until the next decade. To circumvent a disputed outcome in the huge National Institutes of Health-sponsored Diabetes Treatment and Control Study (DCCT) starting this year [3], there has been extensive discussion of which markers of renal disease ought to be followed to gauge any induced benefit to the kidney. Plausible variables applicable to a contemplated study of treatment effect on the kidney are given in table 47-2.


Diabetes Type Diabetic Nephropathy Peritoneal Dialysis Aldose Reductase Insulin Pump 
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  1. 1.
    Gretz N, Strauch M: Delayed progression of chronic renal failure: a prospective controlled trial with a low protein diet supplemented by keto acids. Contrib Nephrol 49: 78–86, 1985.PubMedGoogle Scholar
  2. 2.
    Williams AJ, Bennett SE, Russell GI, Walls J: Alteration of the course of chronic renal failure by dietary protein restriction. Proc Eur Dial Transplant Assoc Eur Ren Assococ 21: 604–607, 1985.Google Scholar
  3. 3.
    The diabetes control and complications trial (DCCT): Design and methodologic considerations for the feasibility phase: the DCCT Research Group. Diabetes 35: 530–545, 1986.Google Scholar

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© Springer Science+Business Media Dordrecht 1988

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  • Eli A. Friedman

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