Twentyfour Ambulatory Pulse Wave Velocity and Central Augmentation Index in Type 2 Diabetes

December 10, 2013 updated by: University of Aarhus
The functionality and reproducibility of pulse wave analysis is investigated in 20 type 2 diabetic patients who had two 24 hour measurements performed within one week with the Arteriograph24 equipment.

Study Overview

Status

Completed

Conditions

Detailed Description

Arteriograph24 is a new monitor for measuring ambulatory blood pressure and additional performing brachial cuff based on analysis of a suprasystolic pulse wave.

The study aim to test the feasibility of ambulatory pulse wave analysis every twenty minute (the fraction of missed measurements)and the reprodicility of pulse wave velocity and central augmentation index in type 2 diabetic patients. In addition we will explore the relation between diurnal variation of brachial blood pressure, central blood pressure and pulse wave velocity.

20 type 2 diabetic patients will have 24h ambulatory blood pressure performed twice with an interval of one week.

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Silkeborg, Denmark, 8600
        • Medical department, Diagnostic Center, Regional Hospital Silkeborg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type 2 diabetes patients recruited from out patient clinic

Description

Inclusion Criteria:

  • Type 2 diabetes

Exclusion Criteria:

  • Atrial fibrillation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fraction of missed pulse wave analysis
Time Frame: Meaured two times with an interval of one week
Measurements of ambulatory blood pressure and pulse wave analysis is performed every twenty minute. The fraction of missed measurements of pulse wave analysis during day time and night time analysis is the final outcome
Meaured two times with an interval of one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reproducibility of pulse wave analysis parameters
Time Frame: Measured two times with an interval of one week
Reproducibility of pulse wave velocity, Central systolic blood pressure and central augmentation index for 24 hour, day and night
Measured two times with an interval of one week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diurnal variation of brachial blood pressure, central blood pressure and pulse wave velocity
Time Frame: Measured two times with an interval of one week
brachial blood pressure, central blood pressure and pulse wava velocity is measured evrey twenty minutes and averaged for day time and night time. the relative reduction at nioght for the parameters are calculated
Measured two times with an interval of one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Regionshospitalet Silkeborg

Investigators

  • Principal Investigator: Klavs W Hansen, MD, dr.med., Medical department, Diagnostic Center, Regional Hospital Silkeborg, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

March 14, 2013

First Submitted That Met QC Criteria

March 14, 2013

First Posted (Estimate)

March 18, 2013

Study Record Updates

Last Update Posted (Estimate)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35522

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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