Aspirin and Enalapril in Microalbuminuric Type 2 Diabetes Mellitus Patients
Recruitment status was Recruiting
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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 |
- urinary albumin excretion
- glomerular filtration rate
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2003 |
| Estimated Study Completion Date: | January 2007 |
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 |
Inclusion Criteria:
- type 2 diabetes mellitus microalbuminuria
Exclusion Criteria:
- ischemic heart disease peptic disease
Contacts and Locations| Contact: Sandra P Silveiro | 55 51 33325188 | sandrasilveiro@terra.com.br |
| 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 | |
| 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 May 19, 2013