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

• Conditions: Type 2 Diabetes Mellitus; Blood Pressure
• Interventions: Procedure: Blood pressure measurement based on HBP or CBP

• Registration Number: NCT01557972
• Lead Sponsor: Nagaoka Red Cross Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-11
• Status Verified: 2012-03
• Study First Submitted: 2012-03-08
• Study First Submitted QC: 2012-03-16
• Last Update Submitted: 2012-03-16
• Study First Posted: 2012-03-20
• Last Update Posted: 2012-03-20
• Primary Completion: 2013-02
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1. Morning HP and NT	Blood pressure measurement based on HBP or CBP	Subjects based on HBP were divided into MH and MN patients
2. Clinic HP and NT	Blood pressure measurement based on HBP or CBP	Subjects based on CBP were divided into CH and CN patients

Primary Outcome Measures

Name	Time	Method
Death	Average time is 10 years	Number of participats not alive

Secondary Outcome Measures

Name	Time	Method
Macrovascular complications	Average time is 10 years
Microvascular complications including renal anemia	Average time is 10 years

Trial Locations

Locations (1)

Nagaoka Red Cross Hospital; 🇯🇵 Nagaoka, Niigata, Japan