Aspirin and Enalapril in Microalbuminuric Type 2 Diabetes Mellitus Patients
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...
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”
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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 Investigator Information
Lead Investigator: Hospital de Clinicas de Porto Alegre Other
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 February 09, 2012
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 content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00427271
