Overview

This trial is active, not recruiting.

Conditions diabetes mellitus, arterial hypertension
Treatments metformin, glybenclamide, nph insulin, hydrochlorothiazide, propranolol, captopril, amlodipine
Sponsor Hospital de Clinicas de Porto Alegre
Collaborator Conselho Nacional de Desenvolvimento Científico e Tecnológico
Start date July 2006
End date January 2012
Trial size 124 participants
Trial identifier NCT00935805, 06260

Summary

The aim of this study is to to analyze if it is possible to reach the goals of HbA1c <7.0% and blood pressure <= 130/80 mm Hg in a cohort of patients with type 2 diabetes attending a primary care unit, using ony those resources available at the unit, and provided by the Brazilian National Health System. It is an open label, observational study, with a duration of 4-6 years. Patients attending a primary care outpatient facility will be sequentially included in the study provided they give consent. They will be followed on a monthly basis by a team of physicians and nurses. Glucose, A1c, Blood PRessure will be the outcomes.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
124 patients attending the primary care unit included after formal consent.
metformin Initial drug added to non-pharmacological measures
850 mg TID
glybenclamide Second oral agent to be added
10 mg BID
nph insulin Insulin added to or substituted for OA
Variable SC dose
hydrochlorothiazide Inital RX for hypertension
25 mg QD introduced as initial therapy for hypertension
propranolol Introduced if diuretic + captopril do not control BP
40 mg BID
captopril Added to hydrochlorothiazide if BP not attained
50 mg TID
amlodipine Added to previous if BP control BP not satisfactory
10 mg QD

Primary Outcomes

Measure
Glycated hemoglobin A1c
time frame: 3 months
Blood pressure
time frame: 1 month

Secondary Outcomes

Measure
24 hr blood glucose profile
time frame: once
Fasting blood glucose
time frame: 3 months

Eligibility Criteria

Male or female participants from 30 years up to 85 years old.

Inclusion Criteria: - Type 2 diabetes mellitus (WHO) Exclusion Criteria: - Terminal disease (renal, cancer, heart failure)

Additional Information

Official title ANALYSIS OF THE EFFECTIVENESS OF A STAGED MANAGEMENT PROGRAM AIMED AT CONTROLLING BLOOD PRESSURE AND BLOOD GLUCOSE OF TYPE 2 DIABETIC PATIENTS USING EXCLUSIVELY THE RESOURCES AVAILABLE IN A PRIMARY CARE SETTING IN BRAZIL
Principal investigator Rogerio Friedman, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by Hospital de Clinicas de Porto Alegre.