Clinical trial NCT01298726: Pharmaceutical Care in Type 2 Diabetes
Official title: Pharmaceutical Care Program for Users of Brazilian Public Health Care System With Type 2 Diabetes Mellitus: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: DIABETES MELLITUS, TYPE 2
Keywords: PHARMACEUTICAL SERVICES
DIABETES MELLITUS
Lead sponsor: Universidade Federal de Ouro Preto
Sponsor class: OTHER
First posted: 2011-02-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to examine the effect of a pharmaceutical care program on the level of glycated hemoglobin for hyperglycemic users of brazilian public health care system in drug treatment for type 2 diabetes.

Detailed description: The chronic diseases, including diabetes mellitus (DM) are a major public health problems of today. There is evidence that glycated hemoglobin (A1C) levels above 7% are associated with a progressively greater risk of chronic complications related to DM. However, approximately 60% of diabetics do not achieve glycemic control. In Brazil, pharmacists are not involved in direct care of patients with DM. The investigators conducted a randomized controlled trial, for six months, in Ouro Preto, Minas terais to determine the effect of pharmaceutical intervention on glycemic control in patients with diabetes and hyperglycemic (A1C \> 7%). One hundred and twenty-nine subjects were randomized to receive usual care only or usual care and pharmaceutical intervention. The population of those who had access in the brazilian public health care system, as consultations with doctors, nurses and nutritionists, laboratory tests and access to essential medicines were considered as conventional health care.

Eligibility criteria: Inclusion Criteria:

* MINIMAL AGE 18 YEARS OLD
* USE OF DIABETES ORAL MEDICATION
* MINIMAL GLYCOHEMOGLOBIN 7%

Exclusion Criteria:

* PREGNANT AND NURSING WOMEN
* PEOPLE UNABLE TO ATTEND THE STUDY SITE
* PARTICIPANTS OF OTHER PROGRAMS OF PHARMACEUTICAL CARE

Primary outcomes:
measure: GLYCATED HEMOGLOBIN (A1C) LEVELS
timeFrame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
Secondary outcomes:
measure: FASTING GLUCOSE LEVELS
timeFrame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
measure: TOTAL CHOLESTEROL LEVELS
timeFrame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
measure: LDL CHOLESTEROL LEVELS
timeFrame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
measure: HDL CHOLESTEROL LEVELS
timeFrame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
measure: TRIGLYCERIDES LEVELS
timeFrame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
measure: SYSTOLIC BLOOD PRESSURE LEVELS
timeFrame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
measure: DIASTOLIC BLOOD PRESSURE LEVELS
timeFrame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
Other outcomes:
Locations:
city: Ouro Preto
country: Brazil
facility: Universidade Federal de Ouro Preto
state: Minas Gerais
Study officials:
affiliation: Universidade Federal de Ouro Preto
name: LISIANE S EV, DR
role: STUDY_CHAIR
affiliation: Universidade Federal de Ouro Preto
name: ANDREA G GRABE, DR
role: STUDY_DIRECTOR
References: