Aspirin and Enalapril in Microalbuminuric Type 2 Diabetes Mellitus Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2007-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus Microalbuminuria

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

aspirin enalapril microalbuminuria glomerular filtration rate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

aspirin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* type 2 diabetes mellitus microalbuminuria

Exclusion Criteria

* ischemic heart disease peptic disease

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eduardo G Camargo

Role: STUDY_DIRECTOR

Programa de Pós-graduação em Ciências Médicas: Endocrinologia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital de Clínicas de Porto Aelgre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sandra P Silveiro

Role: CONTACT

Phone: 55 51 33325188

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sandra P Silveiro, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

02-353

Identifier Type: -

Identifier Source: org_study_id