Back to resultsPharmaceutical Care in Type 2 Diabetes
Primary Purpose
DIABETES MELLITUS, TYPE 2
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
PHARMACEUTICAL CARE
HEALTH USUAL CARE
Sponsored by
About this trial
This is an interventional supportive care trial for DIABETES MELLITUS, TYPE 2 focused on measuring PHARMACEUTICAL SERVICES, DIABETES MELLITUS
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
Sites / Locations
- Universidade Federal de Ouro Preto
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
PHARMACEUTICAL CARE
HEALTH USUAL CARE
Arm Description
Outcomes
Primary Outcome Measures
GLYCATED HEMOGLOBIN (A1C) LEVELS
glycated hemoglobin levels was determined in the laboratory by high-performance liquid chromatography (HPLC) using venous blood as a sample
Secondary Outcome Measures
FASTING GLUCOSE LEVELS
fasting glucose levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample
TOTAL CHOLESTEROL LEVELS
total cholesterol levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample
LDL CHOLESTEROL LEVELS
LDL levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample
HDL CHOLESTEROL LEVELS
HDL levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample
TRIGLYCERIDES LEVELS
triglycerides levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample
SYSTOLIC BLOOD PRESSURE LEVELS
blood pressure levels was determined by indirect method with digital sphygmomanometer, Omron HEM 742
DIASTOLIC BLOOD PRESSURE LEVELS
blood pressure levels was determined by indirect method with digital sphygmomanometer, Omron HEM 742
Full Information
NCT ID
NCT01298726
First Posted
February 17, 2011
Last Updated
February 17, 2011
Sponsor
Universidade Federal de Ouro Preto
1. Study Identification
Unique Protocol Identification Number
NCT01298726
Brief Title
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
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Universidade Federal de Ouro Preto
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
DIABETES MELLITUS, TYPE 2
Keywords
PHARMACEUTICAL SERVICES, DIABETES MELLITUS
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PHARMACEUTICAL CARE
Arm Type
Other
Arm Title
HEALTH USUAL CARE
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
PHARMACEUTICAL CARE
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
HEALTH USUAL CARE
Intervention Description
Usual care as defined in health consultations with doctors, nutritionists and nurses, access to laboratory tests and essential medicines
Primary Outcome Measure Information:
Title
GLYCATED HEMOGLOBIN (A1C) LEVELS
Description
glycated hemoglobin levels was determined in the laboratory by high-performance liquid chromatography (HPLC) using venous blood as a sample
Time Frame
AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
Secondary Outcome Measure Information:
Title
FASTING GLUCOSE LEVELS
Description
fasting glucose levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample
Time Frame
AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
Title
TOTAL CHOLESTEROL LEVELS
Description
total cholesterol levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample
Time Frame
AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
Title
LDL CHOLESTEROL LEVELS
Description
LDL levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample
Time Frame
AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
Title
HDL CHOLESTEROL LEVELS
Description
HDL levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample
Time Frame
AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
Title
TRIGLYCERIDES LEVELS
Description
triglycerides levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample
Time Frame
AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
Title
SYSTOLIC BLOOD PRESSURE LEVELS
Description
blood pressure levels was determined by indirect method with digital sphygmomanometer, Omron HEM 742
Time Frame
AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
Title
DIASTOLIC BLOOD PRESSURE LEVELS
Description
blood pressure levels was determined by indirect method with digital sphygmomanometer, Omron HEM 742
Time Frame
AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LISIANE S EV, DR
Organizational Affiliation
Universidade Federal de Ouro Preto
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
ANDREA G GRABE, DR
Organizational Affiliation
Universidade Federal de Ouro Preto
Official's Role
Study Director
Facility Information:
Facility Name
Universidade Federal de Ouro Preto
City
Ouro Preto
State/Province
Minas Gerais
ZIP/Postal Code
35400-000
Country
Brazil
12. IPD Sharing Statement
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Pharmaceutical Care in Type 2 Diabetes
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