Pharmaceutical Services Clinical Trial
Official title:
Effectiveness of Pharmacotherapy Follow-up Care in Outpatients With Type 2 Diabetes Mellitus: Randomized Clinical Trial
Hypothesis: Pharmacotherapy follow-up can improve clinical outcomes of outpatients with type
2 diabetes mellitus.
Methods: In this single blind, placebo-controlled trial, the participants with type 2
diabetes mellitus are randomized into two groups:
1. pharmaceutical care intervention (n=30, attended by the protocol of follow-up) and
2. control (n=30, attended by the usual procedure of dispensing).
Primary outcomes evaluated are: hospitalization (percentage of participants hospitalized),
severe evolving complication - ischemic or proliferative retinopathy, severe renal
insufficiency, severe hypoglycemia, coronaropathy or evolving foot lesion (presence or
absence).
Other parameter checked: A1c hemoglobin (HbA1c), blood glucose (BG), blood pressure (BP),
total cholesterol (TC), waist circumference (WC), body mass index (BMI) and mortality. The
investigators follow up all patients for up to 12 months.
Background. Few Brazilian randomized controlled trials have established the benefits of
pharmacotherapy follow-up in care of outpatients with type 2 diabetes mellitus in low-middle
income country. This study evaluate the effectiveness of pharmacotherapy follow-up care to
get better outcomes in outpatients with type 2 diabetes mellitus attended in the public
health service in Brazil.
Method: In this single blind, placebo-controlled trial, the investigators random patients
with type 2 diabetes mellitus into two groups: 1) pharmaceutical care intervention (n=30,
attended by the protocol of follow-up) and 2) control (n=30, attended by the usual procedure
of dispensing).
Primary outcomes checked are: percentage of hospitalization, severe evolving complication
(ischemic or proliferative retinopathy, severe renal insufficiency, severe hypoglycemia,
coronaropathy and evolving foot lesion).
The investigators also check: A1c hemoglobin (HbA1c), blood glucose (BG), blood pressure
(BP), total cholesterol (TC), HbA1c/BP, HbA1c/TC, waist circumference (WC), body mass index
(BMI) and mortality. The participants are followed up to 12 months.
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