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Completed

NCT Number: NCT01298726

Pharmaceutical Care in Type 2 Diabetes

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de Ouro Preto

Ouro Preto, Minas Gerais, 35400-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmaceutical care

Other

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

Usual care as defined in health consultations with doctors, nutritionists and nurses, access to laboratory tests and essential medicines

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidade Federal de Ouro Preto

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 18, 2011
Registry last updated
Feb 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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