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Aspirin and Enalapril in Microalbuminuric Type 2 Diabetes Mellitus Patients

Primary Purpose

Diabetes Mellitus, Microalbuminuria

Status

Unknown status

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

aspirin

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring aspirin, enalapril, microalbuminuria, glomerular filtration rate

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

type 2 diabetes mellitus microalbuminuria

Exclusion Criteria:

ischemic heart disease peptic disease

Sites / Locations

Hospital de Clínicas de Porto AelgreRecruiting

Outcomes

Primary Outcome Measures

urinary albumin excretion

glomerular filtration rate

Secondary Outcome Measures

Full Information

NCT ID

NCT00427271

First Posted

January 26, 2007

Last Updated

January 26, 2007

Sponsor

Hospital de Clinicas de Porto Alegre

1. Study Identification

Unique Protocol Identification Number

NCT00427271

Brief Title

Aspirin and Enalapril in Microalbuminuric Type 2 Diabetes Mellitus Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2007

Overall Recruitment Status

Unknown status

Study Start Date

March 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital de Clinicas de Porto Alegre

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Microalbuminuria

Keywords

aspirin, enalapril, microalbuminuria, glomerular filtration rate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

20 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

aspirin

Primary Outcome Measure Information:

Title

urinary albumin excretion

Title

glomerular filtration rate

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: type 2 diabetes mellitus microalbuminuria Exclusion Criteria: ischemic heart disease peptic disease

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sandra P Silveiro

Phone

55 51 33325188

sandrasilveiro@terra.com.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eduardo G Camargo

Organizational Affiliation

Programa de Pós-graduação em Ciências Médicas: Endocrinologia

Official's Role

Study Director

Facility Information:

Facility Name

Hospital de Clínicas de Porto Aelgre

City

Porto Alegre

State/Province

ZIP/Postal Code

900035900

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sandra P Silveiro, MD

Phone

55 51 33325188

sandrasilveiro@terra.com.br

First Name & Middle Initial & Last Name & Degree

Sandra P Silveiro, MD

First Name & Middle Initial & Last Name & Degree

Eduardo G Camargo, MD

12. IPD Sharing Statement

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Aspirin and Enalapril in Microalbuminuric Type 2 Diabetes Mellitus Patients

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