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

March 16, 2012 updated by: Kyuzi Kamoi, Nagaoka Red Cross Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Niigata
      • Nagaoka, Niigata, Japan, 940-2085
        • Nagaoka Red Cross Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

400 patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1. Morning HP and NT
Subjects based on HBP were divided into MH and MN patients
Procedure: Blood pressure measurement based on HBP or CBP
To clarify which of HBP or CBP provides the stronger prediction power for the outcomes.
Procedure: Blood pressure measurement based on HBP or CBP
To clarify which of HBP or CBP provides the stronger predictive power for the outcomes
2. Clinic HP and NT
Subjects based on CBP were divided into CH and CN patients
Procedure: Blood pressure measurement based on HBP or CBP
To clarify which of HBP or CBP provides the stronger prediction power for the outcomes.
Procedure: Blood pressure measurement based on HBP or CBP
To clarify which of HBP or CBP provides the stronger predictive power for the outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: Average time is 10 years
Number of participats not alive
Average time is 10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Microvascular complications including renal anemia
Time Frame: Average time is 10 years
Average time is 10 years
Macrovascular complications
Time Frame: Average time is 10 years
Average time is 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nagaoka Red Cross Hospital

Investigators

  • Principal Investigator: Kyuzi Kamoi, MD, Nagaoka Red Cross Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1999

Primary Completion (Anticipated)

February 1, 2013

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

March 8, 2012

First Submitted That Met QC Criteria

March 16, 2012

First Posted (Estimate)

March 20, 2012

Study Record Updates

Last Update Posted (Estimate)

March 20, 2012

Last Update Submitted That Met QC Criteria

March 16, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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