Clinical trial NCT00803660: Survey on the Treatment of Hypertension in Patients With Type 2 Diabetes
Official title: In Practice Survey on the Treatment of Hypertension in Patients With Type 2 Diabetes.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Type 2 Diabetes
Keywords: hypertension
BP
diabetes
anti-hypertensive treatment
ACE-I
ARB
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-12-05
Enrollment: 1060
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: type 2 diabetic patients who are currently using antihypertensive treatment for at least 3 months, with same regimen for a minimum of 4 weeks prior to the survey

Brief summary: Multi-centre survey of type 2 diabetic patients who are currently on anti-hypertensive treatment. Data collection for each patient will take place at one visit. To observe the proportion of diabetic patients on antihypertensive treatment reaching the BP\<130/80 mmHg. To observe the proportion of diabetic patients on antihypertensive treatment reaching the BP\<130/80 mmHg by treatment groups. To observe the proportion of patients achieving a therapeutic glycemic response defined as HbA1c=\<7%. To observe the proportion of patients achieving fasting plasma glucose\<110 mg%. To identify factors for not achieving BP\<130/80 mmHg. To describe percentage of patients with positive proteinuria (including microalbuminuria) by treatment groups .


Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent
* Patient was diagnosed with type 2 diabetes
* Patient is on antihypertensive treatments for at least 3 months, with the same regimen for a minimum of 4 weeks prior to survey

Exclusion Criteria:

* Patients are critically ill, had mental health problems or difficulty in communication
* Patients who are unwilling or unable to provide informed consent
* Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site).

Primary outcomes:
measure: The number of patients achieving the BP<130/80 mmHg
measure: The percentage of patients achieving the BP<130/80 mmHg
Secondary outcomes:
measure: The number and percentage of patients achieving the BP<130/80 mmHg by treatment groups
measure: The number and percentage of patients achieving HbA1c=<7%
measure: The number and percentage of patients achieving the FPG<110 mg%
measure: The association between unachievement of BP<130/80 mmHg and other factors (age, gender, CV risk factors, CV and diabetes history, duration of type of treatment...)
measure: The number and percentage of patients with positive proteinuria by treatment groups
Other outcomes:
Locations:
city: Qui Nhon
country: Vietnam
facility: Research Site
state: Binh Dinh
city: Buon Me Thuoc
country: Vietnam
facility: Research Site
state: Dak Lak
city: Bien Hoa
country: Vietnam
facility: Research Site
state: Dong Nai
city: Thong Nhat
country: Vietnam
facility: Research Site
state: Dong Nai
city: Nha Trang
country: Vietnam
facility: Research Site
state: Khanh Hoa
city: Hue
country: Vietnam
facility: Research Site
state: Thua Thien
city: An Giang
country: Vietnam
facility: Research Site
city: Bac Lieu
country: Vietnam
facility: Research Site
city: Ca Mau
country: Vietnam
facility: Research Site
city: Can Tho
country: Vietnam
facility: Research Site
city: Da Nang
country: Vietnam
facility: Research Site
city: Dong Thap
country: Vietnam
facility: Research Site
city: Hai Phong
country: Vietnam
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Kien Giang
country: Vietnam
facility: Research Site
city: Nam Dinh
country: Vietnam
facility: Research Site
city: Thai Binh
country: Vietnam
facility: Research Site
city: Tien Giang
country: Vietnam
facility: Research Site
Study officials:
affiliation: University of Medicine and Pharmacy of HCMC
name: Dang Van Phuoc, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tam Duc Heart Hospital
name: Pham Nguyen Vinh, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Vietnam Heart Association
name: Pham Gia Khai, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Endocrinology and Diabetes Association of HCMC
name: Nguyen Thy Khue, PhD
role: PRINCIPAL_INVESTIGATOR
References: