Aspirin and Enalapril in Microalbuminuric Type 2 Diabetes Mellitus Patients

Phase 4

• Conditions: Diabetes Mellitus; Microalbuminuria

• Registration Number: NCT00427271
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2003-03
• Status Verified: 2007-01
• Study Completion: 2007-01
• Study First Submitted: 2007-01-26
• Study First Submitted QC: 2007-01-26
• Last Update Submitted: 2007-01-26
• Study First Posted: 2007-01-29
• Last Update Posted: 2007-01-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• type 2 diabetes mellitus microalbuminuria

Exclusion Criteria

• ischemic heart disease peptic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
urinary albumin excretion
glomerular filtration rate

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Aelgre; 🇧🇷 Porto Alegre, RS, Brazil