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...
Date First Received: January 26, 2007
Last Updated: January 26, 2007
Verified by: Hospital de Clinicas de Porto Alegre, January 2007
Clinical Trial Phase: Phase 4 | Start Date: March 2003
Overall Status: Recruiting
Estimated Enrollment: 20
Brief Summary
Official Title: “Aspirin and the Antiproteinuric Effect of Enalapril in Microalbuminuric Type 2 Diabetes Mellitus Patients: a Randomized, Double-Blind, Placebo-Controlled Study”
Condition Keyword(s):
Intervention(s):
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
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: aspirin
Outcome Measures for this Clinical Trial
Primary Measures
- urinary albumin excretion
- glomerular filtration rate
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- type 2 diabetes mellitus microalbuminuria
Exclusion Criteria:
- ischemic heart disease peptic disease
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 30 Years
Maximum Age for this Clinical Trial: 80 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Hospital de Clinicas de Porto Alegre
Overall Clinical Trial Officials and Contacts
Eduardo G Camargo Study Director Programa de Pós-graduação em Ciências Médicas: Endocrinologia
Overall Contact: Sandra P Silveiro 55 51 33325188 sandrasilveiro@terra.com.br
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00427271
Study ID Number: 02-353
ClinicalTrials.gov Identifier: NCT00427271
Health Authority: Brazil: National Committee of Ethics in Research
Clinical Trials Authorship and Review
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