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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kyuzi Kamoi, Nagaoka Red Cross Hospital
ClinicalTrials.gov Identifier:
NCT01557972
First received: March 8, 2012
Last updated: March 16, 2012
Last verified: March 2012
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) (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:

U.S. FDA Resources

Further study details as provided by Nagaoka Red Cross Hospital:

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


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

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

Ages Eligible for Study:   20 Years to 95 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:

Responsible Party: Kyuzi Kamoi, Investigator, Nagaoka Red Cross Hospital
ClinicalTrials.gov Identifier: NCT01557972     History of Changes
Other Study ID Numbers: 5
Study First Received: March 8, 2012
Last Updated: March 16, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013