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Pharmaceutical Care in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01298726
Recruitment Status : Completed
First Posted : February 18, 2011
Last Update Posted : February 18, 2011
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment
DIABETES MELLITUS, TYPE 2 Other: PHARMACEUTICAL CARE Other: HEALTH USUAL CARE

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2010
Primary Completion Date : September 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: February 18, 2011    Key Record Dates
Last Update Posted: February 18, 2011
Last Verified: January 2011

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