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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00935805
• Other study ID #: 06260
• Status: Active, not recruiting
• Phase: N/A
• First received: July 8, 2009
• Last updated: October 25, 2011
• Start date: July 2006
• Est. completion date: July 2012

Study information

• Verified date: July 2011
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 124
• Est. completion date: July 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes mellitus (WHO)

Exclusion Criteria:

• Terminal disease (renal, cancer, heart failure)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arterial Hypertension
• Diabetes Mellitus
• Hypertension

Intervention

Drug:
• Metformin
850 mg TID
• Glybenclamide
10 mg BID
• NPH insulin
Variable SC dose
• Hydrochlorothiazide
25 mg QD introduced as initial therapy for hypertension
• Propranolol
40 mg BID
• Captopril
50 mg TID
• Amlodipine
10 mg QD

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (3)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated hemoglobin A1c		3 months	No
Primary	Blood pressure		1 month	No
Secondary	24 hr blood glucose profile		once	No
Secondary	Fasting blood glucose		3 months	No