Aspirin and Enalapril in Microalbuminuric Type 2 Diabetes Mellitus Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Hospital de Clinicas de Porto Alegre.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00427271
First received: January 26, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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 Intervention Phase
Diabetes Mellitus
Microalbuminuria
Drug: aspirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • urinary albumin excretion
  • glomerular filtration rate

Estimated Enrollment: 20
Study Start Date: March 2003
Estimated Study Completion Date: January 2007
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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • type 2 diabetes mellitus microalbuminuria

Exclusion Criteria:

  • ischemic heart disease peptic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00427271     History of Changes
Other Study ID Numbers: 02-353
Study First Received: January 26, 2007
Last Updated: January 26, 2007
Health Authority: Brazil: National Committee of Ethics in Research

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
Albuminuria
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Aspirin
Enalapril
Enalaprilat
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on April 22, 2014