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

NCT00760110 | Completed

• 1 other identifier: 1
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

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). 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.

Conditions

Hypertension; Type 2 Diabetes

Keywords

Morning BP; Clinic BP; micro- and macrovascular complications

Outcome Measures

Primary Outcomes (1)

• Death

  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

Secondary Outcomes (2)

• Microvascular complications

  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

• Macrovascular complications

  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

Study Arms (2)

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

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

Interventions

blood pressure measurements based on HBP or CBP DEVICE

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

1 Morning hypertension and normotension; 2 Clinic hypertension and normotension

Eligibility Criteria

• Age: 23 Years - 87 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Type 2 diabetic patients with HBP and CBP measurements

You may not qualify if:

• Type 1 or 2 diabetic patients without HBP and CBP measurements

Sponsors & Collaborators

• Nagaoka Red Cross Hospital: lead

Related Publications (1)

• 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: 20504126 DERIVED

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine 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

Study Record Dates

• First Submitted: September 25, 2008
• First Posted: September 26, 2008
• Study Start: November 1, 1997
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: October 1, 2008

Record last verified: 2008-09