Pharmaceutical Care in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Universidade Federal de Ouro Preto
ClinicalTrials.gov Identifier:
NCT01298726
First received: February 17, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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.


Condition Intervention
DIABETES MELLITUS, TYPE 2
Other: PHARMACEUTICAL CARE
Other: HEALTH USUAL CARE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Pharmaceutical Care Program for Users of Brazilian Public Health Care System With Type 2 Diabetes Mellitus: Randomized Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Universidade Federal de Ouro Preto:

Primary Outcome Measures:
  • GLYCATED HEMOGLOBIN (A1C) LEVELS [ Time Frame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) ] [ Designated as safety issue: No ]
    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 [ Time Frame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) ] [ Designated as safety issue: No ]
    fasting glucose levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample

  • TOTAL CHOLESTEROL LEVELS [ Time Frame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) ] [ Designated as safety issue: No ]
    total cholesterol levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample

  • LDL CHOLESTEROL LEVELS [ Time Frame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) ] [ Designated as safety issue: No ]
    LDL levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample

  • HDL CHOLESTEROL LEVELS [ Time Frame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) ] [ Designated as safety issue: No ]
    HDL levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample

  • TRIGLYCERIDES LEVELS [ Time Frame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) ] [ Designated as safety issue: No ]
    triglycerides levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample

  • SYSTOLIC BLOOD PRESSURE LEVELS [ Time Frame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) ] [ Designated as safety issue: No ]
    blood pressure levels was determined by indirect method with digital sphygmomanometer, Omron HEM 742

  • DIASTOLIC BLOOD PRESSURE LEVELS [ Time Frame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) ] [ Designated as safety issue: No ]
    blood pressure levels was determined by indirect method with digital sphygmomanometer, Omron HEM 742


Enrollment: 100
Study Start Date: January 2010
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298726

Locations
Brazil
Universidade Federal de Ouro Preto
Ouro Preto, Minas Gerais, Brazil, 35400-000
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: LISIANE DA SILVEIRA EV, UNIVERSIDADE FEDERAL DE OURO PRETO
ClinicalTrials.gov Identifier: NCT01298726     History of Changes
Other Study ID Numbers: 0040.0.238.000-09
Study First Received: February 17, 2011
Last Updated: February 17, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Federal de Ouro Preto:
PHARMACEUTICAL SERVICES
DIABETES MELLITUS

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014