Effect of Patient Education Related to Cardiovascular Risk Factors in Type 2 Diabetes Mellitus - Full Text View

Effect of Patient Education Related to Cardiovascular Risk Factors in Type 2 Diabetes Mellitus (PATROL)

This study is not yet open for participant recruitment.

Verified by AstraZeneca, April 2009

First Received: April 28, 2009 Last Updated: April 30, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00891124

Purpose

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.

Condition
Glycemia Hypertension Hyperlipidemia

MedlinePlus related topics: Diabetes High Blood Pressure

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The treatment goal of risk factors is based on ADA guideline. [ Time Frame: At baseline and Endpiont (after 2months) ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	4000
Study Start Date:	May 2009
Estimated Study Completion Date:	May 2010

Groups/Cohorts
1 Type II DM and Hypertension and/or Hyperlipidemia

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Type II DM and Hypertension and/or Hyperlipidemia

Criteria

Inclusion Criteria:

Patients who had been diagnosed with type II diabetes mellitus
Patients with hypertension and / or hyperlipidemia
Patients who had agreed to Informed

Exclusion Criteria:

Patients who had been diagnosed with type I diabetes mellitus
Patients with neither hypertension and hyperlipidemia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891124

Contacts

Contact: MyungHwan Chi

+82-2188-2142

myunghwan.chi@astrazeneca.com

Locations

Korea, Republic of
Research Site
Cheiju, Korea, Republic of
Research Site
Busan, Korea, Republic of
Research SIte
Daegu, Korea, Republic of
Research Site
Sungman, Korea, Republic of
Research Site
Hongsung, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Research Site
Gwangju, Korea, Republic of

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Joonwoo Bahn

ASTRAZENECA, Korea Medical Department

More Information

No publications provided

Responsible Party:	AstraZeneca ( AstraZeneca )
Study ID Numbers:	NIS-CKR-DUM-2009-2
Study First Received:	April 28, 2009
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00891124 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by AstraZeneca:

Hypertension
Type II DM
Hyperlipidemia

Glycemia
ADA 2008 guideline
Patient Consultation

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Diabetes Mellitus, Type 2
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Dyslipidemias
Lipid Metabolism Disorders
Hypertension

Additional relevant MeSH terms:

Metabolic Diseases
Hyperlipidemias
Diabetes Mellitus, Type 2
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases

Cardiovascular Diseases
Glucose Metabolism Disorders
Dyslipidemias
Lipid Metabolism Disorders
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009