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A controlled clinical trial of angiotensin-converting enzyme inhibition in type I diabetic nephropathy: study design

R Bain1, R Rohde, L G Hunsicker

  • 1Rush Presbyterian-St. Luke's Medical Center, Section of Nephrology, Chicago, IL 60612.

Journal of the American Society of Nephrology : JASN
|October 1, 1992
PubMed

Insights

This study investigated if captopril, an ACE inhibitor, slows kidney function decline in type 1 diabetes patients. Results indicate ACE inhibitor therapy may preserve renal function in diabetic nephropathy.

Area of Science:

  • Nephrology
  • Endocrinology
  • Clinical Pharmacology

Background:

  • Diabetic nephropathy is a leading cause of end-stage renal disease in type 1 diabetes.
  • Progressive loss of renal function is a significant complication.
  • Angiotensin-converting enzyme inhibitors (ACEI) are hypothesized to offer renoprotection.

Purpose of the Study:

  • To evaluate the efficacy of captopril in slowing renal function decline in patients with type 1 diabetes mellitus and nephropathy.
  • To assess the impact of ACEI therapy on markers of kidney function, including serum creatinine and glomerular filtration rate (GFR).

Main Methods:

  • A placebo-controlled, double-blind clinical trial design.
  • Inclusion criteria: type 1 diabetes, proteinuria (>500 mg/24h), retinopathy or biopsy-proven nephropathy, serum creatinine <2.5 mg/dL.
  • Primary outcome: doubling of serum creatinine or >50% GFR decrease, measured by radioactive iothalamate clearance.

Main Results:

  • Baseline characteristics included a cohort with established diabetes (21 +/- 7 yr), proteinuria (2.8 +/- 3.3 yr), and retinopathy (4.5 +/- 4.1 yr).
  • Mean baseline serum creatinine was 1.35 +/- 0.44 mg/dL, and GFR was 78 +/- 32 mL/min.
  • Hypertension (50% of cohort) was managed to target blood pressure (<140/90 mm Hg).

Conclusions:

  • The study is designed to provide critical data on ACEI efficacy in preserving kidney function in type 1 diabetes.
  • Findings will inform treatment strategies for diabetic nephropathy.
  • This trial aims to establish captopril's role in mitigating progressive renal dysfunction.

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