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

NCT00935805 — Unknown, 124 participants, Hospital de Clinicas de Porto Alegre
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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

RegistryNCT00935805
StatusUnknown
Study typeObservational
Enrollment124 (Estimated)
SponsorHospital de Clinicas de Porto Alegre (Other); collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
ConditionsDiabetes Mellitus, Arterial Hypertension
InterventionsMetformin, Glybenclamide, NPH insulin, Hydrochlorothiazide, Propranolol, Captopril, Amlodipine (Drug)
Datesstart 2006-07-01, primary completion 2012-01-01 (estimated), completion 2012-07-01 (estimated), first posted 2009-07-09, last updated 2011-10-26
Locations1 site in Brazil

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
TreatmentDrug: Metformin; Drug: Glybenclamide; Drug: NPH insulin; Drug: Hydrochlorothiazide; Drug: Propranolol; Drug: Captopril; Drug: Amlodipine124 patients attending the primary care unit included after formal consent.
  • Metformin (Drug), also known as Initial drug added to non-pharmacological measures: 850 mg TID
  • Glybenclamide (Drug), also known as Second oral agent to be added: 10 mg BID
  • NPH insulin (Drug), also known as Insulin added to or substituted for OA: Variable SC dose
  • Hydrochlorothiazide (Drug), also known as Inital RX for hypertension: 25 mg QD introduced as initial therapy for hypertension
  • Propranolol (Drug), also known as Introduced if diuretic + captopril do not control BP: 40 mg BID
  • Captopril (Drug), also known as Added to hydrochlorothiazide if BP not attained: 50 mg TID
  • Amlodipine (Drug), also known as Added to previous if BP control BP not satisfactory: 10 mg QD

+Outcome measures

Primary outcomes

  • Glycated hemoglobin A1c [3 months]
  • Blood pressure [1 month]

Secondary outcomes

  • 24 hr blood glucose profile [once]
  • Fasting blood glucose [3 months]

+Eligibility

Sex: All, ages: 30 Years to 85 Years

Inclusion Criteria:

* Type 2 diabetes mellitus (WHO)

Exclusion Criteria:

* Terminal disease (renal, cancer, heart failure)

+Locations (1)

FacilityCityCountryStatus
Hospital de Clínicas de Porto AlegrePorto Alegre, Rio Grande do SulBrazil

+Investigators

My Notes