GlycemiaPATROLNCT00891124
Effect of PATient Education Related to CV Risk factOrs in Type 2 Diabetes Mellitus(Patrol).
An observational study of Glycemia and Hypertension, run by AstraZeneca at 7 sites in South Korea.
Trial summary
This study will address the proportion of achievement patients in treatment target goal on glycemic control, hypertension and hyperlipidemia according to ADA 2008 guideline, among outpatients coming to the Korean primary care nationwide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glycemia, Hypertension, Hyperlipidemia
- How many people
- 4,045 participants
- Where
- 7 sitesSouth Korea
- Study dates
- May 2009to Oct 2009
- Phase
- Observational
- 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
Study population: Type II DM and Hypertension and/or Hyperlipidemia
Who may be able to join
- Patients who had been diagnosed with type II diabetes mellitus
- Patients with hypertension and / or hyperlipidemia
- Patients who had agreed to Informed
Who cannot join
- Patients who had been diagnosed with type I diabetes mellitus
- Patients with neither hypertension and hyperlipidemia
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Research Site
Busan
Research Site
Cheiju
Research SIte
Daegu
Research Site
Gwangju
Research Site
Hongseong
Research Site
Seoul
Research Site
Sungman
About this study
Official title: A Multi-center, Prospective, Observational Study to Assess the Effect of Patient Education Related to CV Risk Factors in Type 2 Diabetes Mellitus
This study will address the proportion of achievement patients in treatment target goal on glycemic control, hypertension and hyperlipidemia according to ADA 2008 guideline, among outpatients coming to the Korean primary care nationwide.
- Conditions
- Glycemia, Hypertension, Hyperlipidemia
- Keywords
- Hypertension, Type II DM, Hyperlipidemia, Glycemia, ADA 2008 guideline, Patient Consultation
- Medical subject headings
- Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Type II DM and Hypertension and/or Hyperlipidemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of achievement patients in treatment target goal on glycemic control, hypertension and hyperlipidemia according to ADA 2008 guideline
Measured: At baseline and Endpiont (after 2months)
Secondary outcomes (1)
The treatment goal of risk factors is based on ADA guideline.
Measured: At baseline and Endpiont (after 2months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startMay 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlycemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,045 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joonwoo Bahn, Study director, ASTRAZENECA, Korea Medical Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891124
- Sponsor's protocol ID
- NIS-CKR-DUM-2009/2
- Acronym
- PATROL
- Status last verified
- Nov 2009
- First submitted
- 28 Apr 2009
- Last updated
- 3 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Observational Study to Assess the Effect of Patient Education Related to CV Risk Factors in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00891124
- Acronym / sponsor ID
- PATROL / NIS-CKR-DUM-2009/2
- Conditions
- Glycemia, Hypertension, Hyperlipidemia
- Keywords
- Hypertension, Type II DM, Hyperlipidemia, Glycemia, ADA 2008 guideline, Patient Consultation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,045 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Study completion
- Oct 2009 (actual)
- First posted
- 1 May 2009 (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.
This study will address the proportion of achievement patients in treatment target goal on glycemic control, hypertension and hyperlipidemia according to ADA 2008 guideline, among outpatients coming to the Korean primary care nationwide.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Type II DM and Hypertension and/or Hyperlipidemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type II DM and Hypertension and/or Hyperlipidemia
Key inclusion criteria (3 listed)
- Patients who had been diagnosed with type II diabetes mellitus
- Patients with hypertension and / or hyperlipidemia
- Patients who had agreed to Informed
Key exclusion criteria (2 listed)
- Patients who had been diagnosed with type I diabetes mellitus
- Patients with neither hypertension and hyperlipidemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of achievement patients in treatment target goal on glycemic control, hypertension and hyperlipidemia according to ADA 2008 guideline
Time frame: At baseline and Endpiont (after 2months)
1 secondary outcome
The treatment goal of risk factors is based on ADA guideline.
Time frame: At baseline and Endpiont (after 2months)
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 3 Nov 2009.
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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.
Joonwoo Bahn study director
ASTRAZENECA, Korea Medical Department
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glycemia and Hypertension, run by AstraZeneca at 7 sites in South Korea.
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 2 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 3 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. 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?
Proportion of achievement patients in treatment target goal on glycemic control, hypertension and hyperlipidemia according to ADA 2008 guideline (time frame: At baseline and Endpiont (after 2months)). 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 3 Nov 2009.