Long-term of 10 Years Results of a Prospective Longitudinal Study

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Usefulness of Home Blood Pressure Measurement in the Morning in Type 2 Diabetic Patients : Long-term (10 Years) Results of a Prospective Longitudinal Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01557972
• Other study ID #: 5
• Status: Active, not recruiting
• Phase: N/A
• First received: March 8, 2012
• Last updated: March 16, 2012
• Start date: November 1999
• Est. completion date: March 2013

Study information

• Verified date: March 2012
• Source: Nagaoka Red Cross Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Previous cross-sectional studies have demonstrated that blood pressure (BP) measurements at home (HBP) in the morning offer stronger predictive power for micro- and macrovascular complications in patients with type 1 and 2 diabetes than casual/clinic blood pressure measurements (CBP) (Kamoi K et al, 2002-2003). Further, a prospective, longitudinal study for 6 years in patients with type 2 diabetes also demonstrated that control of wakening-up HBP provides the stronger predictive power for the outcomes than that of CBP did (Kamoi et al, 2010).

However, it is not clear to show which of BP measurement provides the stronger predictive power for outcomes by comparing cumulative events over a longer time than 6 years. Therefore, the investigators examined which of HBP or CBP provides the stronger predictive power for outcomes in addition of renal anemia reported previously over 10 years in the patients with type 2 diabetes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 95 Years

Eligibility

Inclusion Criteria:

• After a detailed baseline examination, 400 Japanese subjects with type 2 diabetes reported previously are followed up for all-cause mortality and morbidity.

Exclusion Criteria:

• Other than the above, patients judged inappropriate as the subjects of this study by the investigator

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Pressure
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Procedure:
• Blood pressure measurement based on HBP or CBP
To clarify which of HBP or CBP provides the stronger prediction power for the outcomes.
• Blood pressure measurement based on HBP or CBP
To clarify which of HBP or CBP provides the stronger predictive power for the outcomes

Locations

Country	Name	City	State
Japan	Nagaoka Red Cross Hospital	Nagaoka	Niigata

Sponsors (1)

Lead Sponsor	Collaborator
Nagaoka Red Cross Hospital

Country where clinical trial is conducted

Japan, 

References & Publications (3)

Kamoi K, Imamura Y, Miyakoshi M, Kobayashi C. Usefulness of home blood pressure measurement in the morning in type 1 diabetic patients. Diabetes Care. 2003 Aug;26(8):2473-5. — View Citation

Kamoi K, Ito T, Miyakoshi M, Minagawa S. Usefulness of home blood pressure measurement in the morning in patients with type 2 diabetes: long-term results of a prospective longitudinal study. Clin Exp Hypertens. 2010 May;32(3):184-92. doi: 10.3109/10641960 — View Citation

Kamoi K, Miyakoshi M, Soda S, Kaneko S, Nakagawa O. Usefulness of home blood pressure measurement in the morning in type 2 diabetic patients. Diabetes Care. 2002 Dec;25(12):2218-23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	Number of participats not alive	Average time is 10 years	Yes
Secondary	Microvascular complications including renal anemia		Average time is 10 years	Yes
Secondary	Macrovascular complications		Average time is 10 years	Yes