Aspirin and Enalapril in Microalbuminuric Type 2 Diabetes Mellitus Patients
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|ClinicalTrials.gov Identifier: NCT00427271|
Recruitment Status : Unknown
Verified January 2007 by Hospital de Clinicas de Porto Alegre.
Recruitment status was: Recruiting
First Posted : January 29, 2007
Last Update Posted : January 29, 2007
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Microalbuminuria||Drug: aspirin||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Aspirin and the Antiproteinuric Effect of Enalapril in Microalbuminuric Type 2 Diabetes Mellitus Patients: a Randomized, Double-Blind, Placebo-Controlled Study|
|Study Start Date :||March 2003|
|Study Completion Date :||January 2007|
- urinary albumin excretion
- glomerular filtration rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00427271
|Contact: Sandra P Silveiro||55 51 firstname.lastname@example.org|
|Hospital de Clínicas de Porto Aelgre||Recruiting|
|Porto Alegre, RS, Brazil, 900035900|
|Contact: Sandra P Silveiro, MD 55 51 33325188 email@example.com|
|Principal Investigator: Sandra P Silveiro, MD|
|Sub-Investigator: Eduardo G Camargo, MD|
|Study Director:||Eduardo G Camargo||Programa de Pós-graduação em Ciências Médicas: Endocrinologia|