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

NCT ID: NCT01557972

Last Updated: 2012-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-11-30

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Blood Pressure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1. Morning HP and NT

Subjects based on HBP were divided into MH and MN patients

Blood pressure measurement based on HBP or CBP

Intervention Type PROCEDURE

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

Blood pressure measurement based on HBP or CBP

Intervention Type PROCEDURE

To clarify which of HBP or CBP provides the stronger predictive power for the outcomes

Interventions

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Blood pressure measurement based on HBP or CBP

To clarify which of HBP or CBP provides the stronger prediction power for the outcomes.

Intervention Type PROCEDURE

Blood pressure measurement based on HBP or CBP

To clarify which of HBP or CBP provides the stronger predictive power for the outcomes

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nagaoka Red Cross Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kyuzi Kamoi

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyuzi Kamoi, MD

Role: PRINCIPAL_INVESTIGATOR

Nagaoka Red Cross Hospital

Locations

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Nagaoka Red Cross Hospital

Nagaoka, Niigata, Japan

Site Status

Countries

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Japan

References

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Kamoi K, Miyakoshi M, Soda S, Kaneko S, Nakagawa O. Usefulness of home blood pressure measurement in the morning in type 2 diabetic patients. Diabetes Care. 2002 Dec;25(12):2218-23. doi: 10.2337/diacare.25.12.2218.

Reference Type RESULT
PMID: 12453964 (View on PubMed)

Kamoi K, Imamura Y, Miyakoshi M, Kobayashi C. Usefulness of home blood pressure measurement in the morning in type 1 diabetic patients. Diabetes Care. 2003 Aug;26(8):2473-5. doi: 10.2337/diacare.26.8.2473. No abstract available.

Reference Type RESULT
PMID: 12882886 (View on PubMed)

Kamoi K, Ito T, Miyakoshi M, Minagawa S. Usefulness of home blood pressure measurement in the morning in patients with type 2 diabetes: long-term results of a prospective longitudinal study. Clin Exp Hypertens. 2010 May;32(3):184-92. doi: 10.3109/10641960903254513.

Reference Type RESULT
PMID: 20504126 (View on PubMed)

Other Identifiers

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5

Identifier Type: -

Identifier Source: org_study_id

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