DIABETES MELLITUS, TYPE 2NCT01298726
Pharmaceutical Care in Type 2 Diabetes
A study testing PHARMACEUTICAL CARE in people with DIABETES MELLITUS, TYPE 2, run by Universidade Federal de Ouro Preto at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DIABETES MELLITUS, TYPE 2
- What is being tested?
- PHARMACEUTICAL CARE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2010to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MINIMAL AGE 18 YEARS OLD
- USE OF DIABETES ORAL MEDICATION
- MINIMAL GLYCOHEMOGLOBIN 7%
Who cannot join
- PREGNANT AND NURSING WOMEN
- PEOPLE UNABLE TO ATTEND THE STUDY SITE
- PARTICIPANTS OF OTHER PROGRAMS OF PHARMACEUTICAL CARE
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de Ouro Preto
Ouro Preto, Minas Gerais, 35400-000
About this study
Official title: 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.
Read the 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.
- Conditions
- DIABETES MELLITUS, TYPE 2
- Being tested
- PHARMACEUTICAL CARE, HEALTH USUAL CARE
- Keywords
- PHARMACEUTICAL SERVICES, DIABETES MELLITUS
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHARMACEUTICAL CAREOther
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 CAREOther
Usual care as defined in health consultations with doctors, nutritionists and nurses, access to laboratory tests and essential medicines
| Study group | Role | What they receive |
|---|---|---|
| PHARMACEUTICAL CARE | Other | Not described Receives: Other: PHARMACEUTICAL CARE |
| HEALTH USUAL CARE | Other | Not described Receives: Other: HEALTH USUAL CARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
GLYCATED HEMOGLOBIN (A1C) LEVELS
glycated hemoglobin levels was determined in the laboratory by high-performance liquid chromatography (HPLC) using venous blood as a sample
Measured: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
Secondary outcomes (7)
FASTING GLUCOSE LEVELS
fasting glucose levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample
Measured: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
TOTAL CHOLESTEROL LEVELS
total cholesterol levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample
Measured: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
LDL CHOLESTEROL LEVELS
LDL levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample
Measured: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
HDL CHOLESTEROL LEVELS
HDL levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample
Measured: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
TRIGLYCERIDES LEVELS
triglycerides levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample
Measured: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
SYSTOLIC BLOOD PRESSURE LEVELS
blood pressure levels was determined by indirect method with digital sphygmomanometer, Omron HEM 742
Measured: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
DIASTOLIC BLOOD PRESSURE LEVELS
blood pressure levels was determined by indirect method with digital sphygmomanometer, Omron HEM 742
Measured: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startJan 2010
- Primary completionSep 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DIABETES MELLITUS, TYPE 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Ouro Preto
- Sponsor type
- University, hospital or other
- Investigators
- LISIANE S EV, DR, Study chair, Universidade Federal de Ouro PretoANDREA G GRABE, DR, Study director, Universidade Federal de Ouro Preto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298726
- Sponsor's protocol ID
- 0040.0.238.000-09
- Status last verified
- Jan 2011
- First submitted
- 17 Feb 2011
- Last updated
- 18 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmaceutical Care Program for Users of Brazilian Public Health Care System With Type 2 Diabetes Mellitus: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01298726
- Acronym / sponsor ID
- 0040.0.238.000-09
- Conditions
- DIABETES MELLITUS, TYPE 2
- Keywords
- PHARMACEUTICAL SERVICES, DIABETES MELLITUS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidade Federal de Ouro PretoUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PHARMACEUTICAL CARE | Other | Other: PHARMACEUTICAL CARE |
| HEALTH USUAL CARE | Other | Other: HEALTH USUAL CARE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- MINIMAL AGE 18 YEARS OLD
- USE OF DIABETES ORAL MEDICATION
- MINIMAL GLYCOHEMOGLOBIN 7%
Key exclusion criteria (3 listed)
- PREGNANT AND NURSING WOMEN
- PEOPLE UNABLE TO ATTEND THE STUDY SITE
- PARTICIPANTS OF OTHER PROGRAMS OF PHARMACEUTICAL CARE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHARMACEUTICAL CAREThe 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 | PHARMACEUTICAL CARE |
| HEALTH USUAL CAREUsual care as defined in health consultations with doctors, nutritionists and nurses, access to laboratory tests and essential medicines | Other | HEALTH USUAL CARE |
Primary outcome
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
7 secondary outcomes
FASTING GLUCOSE LEVELS
Time frame: 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)
LDL CHOLESTEROL LEVELS
Time frame: 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)
TRIGLYCERIDES LEVELS
Time frame: 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)
DIASTOLIC BLOOD PRESSURE LEVELS
Time frame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LISIANE S EV, DR study chair
Universidade Federal de Ouro Preto
ANDREA G GRABE, DR study director
Universidade Federal de Ouro Preto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHARMACEUTICAL CARE in people with DIABETES MELLITUS, TYPE 2, run by Universidade Federal de Ouro Preto at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GLYCATED HEMOGLOBIN (A1C) LEVELS (time frame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2011.