Pharmaceutical Care in Type 2 Diabetes
- Conditions
- DIABETES MELLITUS, TYPE 2
- Interventions
- Other: HEALTH USUAL CAREOther: PHARMACEUTICAL CARE
- Registration Number
- NCT01298726
- Lead Sponsor
- Universidade Federal de Ouro Preto
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- MINIMAL AGE 18 YEARS OLD
- USE OF DIABETES ORAL MEDICATION
- MINIMAL GLYCOHEMOGLOBIN 7%
- PREGNANT AND NURSING WOMEN
- PEOPLE UNABLE TO ATTEND THE STUDY SITE
- PARTICIPANTS OF OTHER PROGRAMS OF PHARMACEUTICAL CARE
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HEALTH USUAL CARE HEALTH USUAL CARE - PHARMACEUTICAL CARE PHARMACEUTICAL CARE -
- Primary Outcome Measures
Name Time Method GLYCATED HEMOGLOBIN (A1C) LEVELS AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) glycated hemoglobin levels was determined in the laboratory by high-performance liquid chromatography (HPLC) using venous blood as a sample
- Secondary Outcome Measures
Name Time Method FASTING GLUCOSE LEVELS AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) fasting glucose levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample
TOTAL CHOLESTEROL LEVELS AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) total cholesterol levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample
LDL CHOLESTEROL LEVELS AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) LDL levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample
HDL CHOLESTEROL LEVELS AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) HDL levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample
SYSTOLIC BLOOD PRESSURE LEVELS AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) blood pressure levels was determined by indirect method with digital sphygmomanometer, Omron HEM 742
TRIGLYCERIDES LEVELS AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) triglycerides levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample
DIASTOLIC BLOOD PRESSURE LEVELS AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) blood pressure levels was determined by indirect method with digital sphygmomanometer, Omron HEM 742
Trial Locations
- Locations (1)
Universidade Federal de Ouro Preto
🇧🇷Ouro Preto, Minas Gerais, Brazil