NCT01557972

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1999

Completed
12.4 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 20, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 20, 2012

Status Verified

March 1, 2012

Enrollment Period

13.3 years

First QC Date

March 8, 2012

Last Update Submit

March 16, 2012

Conditions

Type 2 Diabetes MellitusBlood Pressure

Outcome Measures

Primary Outcomes (1)

  • Death

    Number of participats not alive

    Average time is 10 years

Secondary Outcomes (2)

  • Microvascular complications including renal anemia

    Average time is 10 years

  • Macrovascular complications

    Average time is 10 years

Study Arms (2)

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

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

Interventions

Blood pressure measurement based on HBP or CBPPROCEDURE

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

1. Morning HP and NT

Eligibility Criteria

Age20 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

400 patients

You may qualify if:

  • After a detailed baseline examination, 400 Japanese subjects with type 2 diabetes reported previously are followed up for all-cause mortality and morbidity.

You may not qualify if:

  • Other than the above, patients judged inappropriate as the subjects of this study by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nagaoka Red Cross Hospital

Nagaoka, Niigata, 940-2085, Japan

Location

Related Publications (3)

  • 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.

    PMID: 12453964RESULT

  • 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.

    PMID: 12882886RESULT

  • 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.

    PMID: 20504126RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kyuzi Kamoi, MD

    Nagaoka Red Cross Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

March 8, 2012

First Posted

March 20, 2012

Study Start

November 1, 1999

Primary Completion

February 1, 2013

Study Completion

March 1, 2013

Last Updated

March 20, 2012

Record last verified: 2012-03

Locations

JP(1)