Pharmaceutical Care in Type 2 Diabetes

February 17, 2011 updated by: Universidade Federal de Ouro Preto

Pharmaceutical Care Program for Users of Brazilian Public Health Care System With Type 2 Diabetes Mellitus: Randomized Controlled Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Ouro Preto, Minas Gerais, Brazil, 35400-000
        • Universidade Federal de Ouro Preto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PHARMACEUTICAL CARE
Other: PHARMACEUTICAL 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.
Other: HEALTH USUAL CARE
Other: HEALTH USUAL CARE
Usual care as defined in health consultations with doctors, nutritionists and nurses, access to laboratory tests and essential medicines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GLYCATED HEMOGLOBIN (A1C) LEVELS
Time Frame: 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
AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FASTING GLUCOSE LEVELS
Time Frame: 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
AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
TOTAL CHOLESTEROL LEVELS
Time Frame: 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
AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
LDL CHOLESTEROL LEVELS
Time Frame: 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
AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
HDL CHOLESTEROL LEVELS
Time Frame: 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
AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
TRIGLYCERIDES LEVELS
Time Frame: 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
AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
SYSTOLIC BLOOD PRESSURE LEVELS
Time Frame: 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
AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
DIASTOLIC BLOOD PRESSURE LEVELS
Time Frame: 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
AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Ouro Preto

Investigators

  • Study Chair: LISIANE S EV, DR, Universidade Federal de Ouro Preto
  • Study Director: ANDREA G GRABE, DR, Universidade Federal de Ouro Preto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

February 17, 2011

First Submitted That Met QC Criteria

February 17, 2011

First Posted (Estimate)

February 18, 2011

Study Record Updates

Last Update Posted (Estimate)

February 18, 2011

Last Update Submitted That Met QC Criteria

February 17, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0040.0.238.000-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on DIABETES MELLITUS, TYPE 2

Clinical Trials on PHARMACEUTICAL CARE

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe