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NCT00427271 Clinical Trial

Aspirin and Enalapril in Microalbuminuric Type 2 Diabetes Mellitus Patients

Diabetes Mellitus Clinical Trial

Official title:
Aspirin and the Antiproteinuric Effect of Enalapril in Microalbuminuric Type 2 Diabetes Mellitus Patients: a Randomized, Double-Blind, Placebo-Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00427271
Other study ID # 02-353
Secondary ID
Status Recruiting
Phase Phase 4
First received January 26, 2007
Last updated January 26, 2007
Start date March 2003
Est. completion date January 2007

Study information
Verified date January 2007
Source Hospital de Clinicas de Porto Alegre
Contact Sandra P Silveiro
Phone 55 51 33325188
Email sandrasilveiro@terra.com.br
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date January 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 80 Years
Eligibility Inclusion Criteria:

- type 2 diabetes mellitus microalbuminuria

Exclusion Criteria:

- ischemic heart disease peptic disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• aspirin

Locations
Country Name City State
Brazil Hospital de Clínicas de Porto Aelgre Porto Alegre RS

Sponsors (1)
Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary urinary albumin excretion
Primary glomerular filtration rate
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