Diabetes Mellitus Clinical Trial
Official title:
Aspirin and the Antiproteinuric Effect of Enalapril in Microalbuminuric Type 2 Diabetes Mellitus Patients: a Randomized, Double-Blind, Placebo-Controlled Study
Research design: randomized, double-blind, placebo-controlled crossover study to evaluate the putative interference of low-dose aspirin (for 8 weeks) on enalapril antiproteinuric properties in microalbuminuric type 2 diabetes mellitus patients
Research design: randomized, double-blind, placebo-controlled crossover study Patients:
Microalbuminuric (urinary albumin excretion [UAE]30-300 mg/d)type 2 diabetes mellitus
patients without ischemic heart disease or peptic ulcer Aim:To evaluate the putative
interference of low-dose aspirin (300 mg/d)for 8 weeks)on enalapril antiproteinuric
properties in microalbuminuric type 2 diabetes mellitus patients Study protocol:Crossover
randomization to 8 weeks of enalapril 10 mg/d plus aspirin (300 mg/d) or plus placebo, and a
6-week washout period. Measurement of UAE (immunoturbidimetry) and glomerular filtration
rate (51Cr-EDTA), blood pressure and metabolic control at baseline and at the end of each
period.
Statistical analyses: Bland&Altman analyses for crossover trials.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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