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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Arterial Hypertension

Intervention / Treatment
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* Drug: Metformin
* Drug: Glybenclamide
* Drug: NPH insulin
* Drug: Hydrochlorothiazide
* Drug: Propranolol
* Drug: Captopril
* Drug: Amlodipine


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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment<br>124 patients attending the primary care unit included after formal consent. | Drug: Metformin<br>* 850 mg TID<br>* Other names: Initial drug added to non-pharmacological measures;Drug: Glybenclamide<br>* 10 mg BID<br>* Other names: Second oral agent to be added;Drug: NPH insulin<br>* Variable SC dose<br>* Other names: Insulin added to or substituted for OA;Drug: Hydrochlorothiazide<br>* 25 mg QD introduced as initial therapy for hypertension<br>* Other names: Inital RX for hypertension;Drug: Propranolol<br>* 40 mg BID<br>* Other names: Introduced if diuretic + captopril do not control BP;Drug: Captopril<br>* 50 mg TID<br>* Other names: Added to hydrochlorothiazide if BP not attained;Drug: Amlodipine<br>* 10 mg QD<br>* Other names: Added to previous if BP control BP not satisfactory;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated hemoglobin A1c |  | 3 months | 
| Blood pressure |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hr blood glucose profile |  | once | 
| Fasting blood glucose |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Arterial Hypertension, Treatment, Primary Care