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A Cohort Study of Morning Home Blood Pressure Measurement in Type 2 Diabetic Patients

This study has been completed.
Sponsor:
Information provided by:
Nagaoka Red Cross Hospital
ClinicalTrials.gov Identifier:
NCT00760110
First received: September 25, 2008
Last updated: September 30, 2008
Last verified: September 2008
History of Changes
  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). The present study examined which of HBP or CBP provides the stronger predictive power for outcomes by comparing cumulative events between hypertensive and normotensive patients over 6 years in a prospective, longitudinal study of patients with type 2 diabetes.


Condition Intervention
Hypertension
Type 2 Diabetes
 Device: blood pressure measurements 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 Results of a Prospective Longitudinal Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nagaoka Red Cross Hospital:

Primary Outcome Measures:
  • Death [ Time Frame: Duration varied between individual patients and was as the period of time until MH or CH patient at baseline displayed a change to MN or CN, or until MN or CN patient at baseline displayed a change to MH or CH, respectively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Microvascular complications [ Time Frame: Duration varied between individual patients and was as the period of time until MH or CH patient at baseline displayed a change to MN or CN, or until MN or CN patient at baseline displayed a change to MH or CH, respectively ] [ Designated as safety issue: Yes ]
  • Macrovascular complications [ Time Frame: Duration varied between individual patients and was as the period of time until MH or CH patient at baseline displayed a change to MN or CN, or until MN or CN patient at baseline displayed a change to MH or CH, respectively ] [ Designated as safety issue: Yes ]

Enrollment: 400
Study Start Date: November 1997
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Morning hypertension and normotension
Based on HBP, subjects were divided into MH and MN patients
 Device: blood pressure measurements based on HBP or CBP
To clarify which of HBP or CBP provides the stronger predictive power for the outcomes, the 400 patients were classified as with or without hypertension based on HBP and CBP measurements at baseline
2 Clinic hypertension and normotension
Based on CBP, subjects were divided into CH and CN patients
 Device: blood pressure measurements based on HBP or CBP
To clarify which of HBP or CBP provides the stronger predictive power for the outcomes, the 400 patients were classified as with or without hypertension based on HBP and CBP measurements at baseline

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   23 Years to 87 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects comprised 400 Japanese patients with type 2 diabetes enrolled between 1999 and 2005.

Criteria

Inclusion Criteria:

  • Type 2 diabetic patients with HBP and CBP measurements

Exclusion Criteria:

  • Type 1 or 2 diabetic patients without HBP and CBP measurements
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760110

Sponsors and Collaborators
Nagaoka Red Cross Hospital
Investigators
Principal Investigator: Kyuzi Kamoi, MD Nagaoka Red Cross Hospital
  More Information

No publications provided by Nagaoka Red Cross Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kyuzi Kamoi, Nagaoka Red Cross Hospital
ClinicalTrials.gov Identifier: NCT00760110     History of Changes
Other Study ID Numbers: 1
Study First Received: September 25, 2008
Last Updated: September 30, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Nagaoka Red Cross Hospital:
Morning BP
Clinic BP
micro- and macrovascular complications

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Hypertension
Diabetes Mellitus
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013