DIABETES MELLITUS, TYPE 2
Conditions
Keywords
PHARMACEUTICAL SERVICES, DIABETES MELLITUS
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.
Interventions
OTHERPHARMACEUTICAL CARE
The pharmaceutical care program was characterized by face to face monthly visits to collect information, register information, prepare plan of care for every health problem; identification of drug therapy problems, communication to prescribers the drug therapy problems identified and education of participants to resolve the drug therapy problems.
OTHERHEALTH USUAL CARE
Usual care as defined in health consultations with doctors, nutritionists and nurses, access to laboratory tests and essential medicines
Sponsors
Universidade Federal de Ouro Preto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Brazil
Outcome results
None listed