Glycemic And Blood Pressure Control In Type 2 Diabetes, In A Primary Care Unit: A Staged Management Strategy

• Conditions: Diabetes Mellitus; Arterial Hypertension
• Interventions: Drug: Metformin; Drug: Glybenclamide; Drug: NPH insulin; Drug: Hydrochlorothiazide; Drug: Propranolol; Drug: Captopril; Drug: Amlodipine

• Registration Number: NCT00935805
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2009-07-08
• Study First Submitted QC: 2009-07-08
• Study First Posted: 2009-07-09
• Status Verified: 2011-07
• Last Update Submitted: 2011-10-25
• Last Update Posted: 2011-10-26
• Primary Completion: 2012-01
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Type 2 diabetes mellitus (WHO)

Exclusion Criteria

• Terminal disease (renal, cancer, heart failure)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment	NPH insulin	124 patients attending the primary care unit included after formal consent.
Treatment	Amlodipine	124 patients attending the primary care unit included after formal consent.
Treatment	Metformin	124 patients attending the primary care unit included after formal consent.
Treatment	Hydrochlorothiazide	124 patients attending the primary care unit included after formal consent.
Treatment	Glybenclamide	124 patients attending the primary care unit included after formal consent.
Treatment	Propranolol	124 patients attending the primary care unit included after formal consent.
Treatment	Captopril	124 patients attending the primary care unit included after formal consent.

Primary Outcome Measures

Name	Time	Method
Glycated hemoglobin A1c	3 months
Blood pressure	1 month

Secondary Outcome Measures

Name	Time	Method
24 hr blood glucose profile	once
Fasting blood glucose	3 months

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil