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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
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Microalbuminuria Drug: aspirin Phase 4

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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
Estimated Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. urinary albumin excretion
  2. glomerular filtration rate

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • type 2 diabetes mellitus microalbuminuria

Exclusion Criteria:

  • ischemic heart disease peptic disease
Contacts and Locations

Information from the National Library of Medicine

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


Contacts
Contact: Sandra P Silveiro 55 51 33325188 sandrasilveiro@terra.com.br

Locations
Brazil
Hospital de Clínicas de Porto Aelgre Recruiting
Porto Alegre, RS, Brazil, 900035900
Contact: Sandra P Silveiro, MD    55 51 33325188    sandrasilveiro@terra.com.br   
Principal Investigator: Sandra P Silveiro, MD         
Sub-Investigator: Eduardo G Camargo, MD         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Study Director: Eduardo G Camargo Programa de Pós-graduação em Ciências Médicas: Endocrinologia
More Information

ClinicalTrials.gov Identifier: NCT00427271     History of Changes
Other Study ID Numbers: 02-353
First Posted: January 29, 2007    Key Record Dates
Last Update Posted: January 29, 2007
Last Verified: January 2007

Keywords provided by Hospital de Clinicas de Porto Alegre:
aspirin
enalapril
microalbuminuria
glomerular filtration rate

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Aspirin
Enalapril
Enalaprilat
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Antihypertensive Agents