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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Kyuzi Kamoi, Nagaoka Red Cross Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01557972
First Posted: March 20, 2012
Last Update Posted: March 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kyuzi Kamoi, Nagaoka Red Cross Hospital
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus Blood Pressure Procedure: Blood pressure measurement based on HBP or CBP

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Kyuzi Kamoi, Nagaoka Red Cross Hospital:

Primary Outcome Measures:
  • Death [ Time Frame: Average time is 10 years ]
    Number of participats not alive


Secondary Outcome Measures:
  • Microvascular complications including renal anemia [ Time Frame: Average time is 10 years ]
  • Macrovascular complications [ Time Frame: Average time is 10 years ]

Estimated Enrollment: 400
Study Start Date: November 1999
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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 predictive power for the outcomes

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
400 patients
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557972


Locations
Japan
Nagaoka Red Cross Hospital
Nagaoka, Niigata, Japan, 940-2085
Sponsors and Collaborators
Nagaoka Red Cross Hospital
Investigators
Principal Investigator: Kyuzi Kamoi, MD Nagaoka Red Cross Hospital
  More Information