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

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ClinicalTrials.gov Identifier: NCT01812811
Recruitment Status : Completed
First Posted : March 18, 2013
Last Update Posted : December 11, 2013
Sponsor:
Collaborator:
Regionshospitalet Silkeborg
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
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.

Condition or disease
Type 2 Diabetes

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
Actual Enrollment : 22 participants
Time Perspective: Prospective
Official Title: Twentyfour Ambulatory Pulse Wave Velocity and Central Augmentation Index in Type 2 Diabetes
Study Start Date : September 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

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U.S. FDA Resources




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type 2 diabetes patients recruited from out patient clinic
Criteria

Inclusion Criteria:

  • Type 2 diabetes

Exclusion Criteria:

  • Atrial fibrillation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01812811


Locations
Denmark
Medical department, Diagnostic Center, Regional Hospital Silkeborg
Silkeborg, Denmark, 8600
Sponsors and Collaborators
University of Aarhus
Regionshospitalet Silkeborg
Investigators
Principal Investigator: Klavs W Hansen, MD, dr.med. Medical department, Diagnostic Center, Regional Hospital Silkeborg, Denmark

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01812811     History of Changes
Other Study ID Numbers: 35522
First Posted: March 18, 2013    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013

Keywords provided by University of Aarhus:
pulse wave analysis
pulse wave velocity
Arteriograph24
Ambulatory
diabetes
reproducibility
diurnal variation

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