Diabetes Mellitus, Microalbuminuria
Conditions
Keywords
aspirin, enalapril, microalbuminuria, glomerular filtration rate
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.
Interventions
DRUGaspirin
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* type 2 diabetes mellitus microalbuminuria
Exclusion criteria
* ischemic heart disease peptic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| urinary albumin excretion | — |
| glomerular filtration rate | — |
Countries
Brazil
Contacts
Primary ContactSandra P Silveiro
Outcome results
None listed