Overview

This trial is active, not recruiting.

Conditions type 2 diabetes mellitus, blood pressure
Treatments blood pressure measurement based on hbp or cbp
Sponsor Nagaoka Red Cross Hospital
Start date November 1999
End date February 2013
Trial size 400 participants
Trial identifier NCT01557972, 5

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Subjects based on HBP were divided into MH and MN patients
blood pressure measurement based on hbp or cbp
To clarify which of HBP or CBP provides the stronger prediction power for the outcomes.
Subjects based on CBP were divided into CH and CN patients
blood pressure measurement based on hbp or cbp
To clarify which of HBP or CBP provides the stronger predictive power for the outcomes

Primary Outcomes

Measure
Death
time frame: Average time is 10 years

Secondary Outcomes

Measure
Microvascular complications including renal anemia
time frame: Average time is 10 years
Macrovascular complications
time frame: Average time is 10 years

Eligibility Criteria

Male or female participants from 20 years up to 95 years old.

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

Additional Information

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
Principal investigator Kyuzi Kamoi, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Nagaoka Red Cross Hospital.