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

This study is currently recruiting participants.
Verified March 2013 by University of Aarhus
Sponsor:
Collaborator:
Regionshospitalet Silkeborg
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01812811
First received: March 14, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
  Purpose

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
Type 2 Diabetes

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Twentyfour Ambulatory Pulse Wave Velocity and Central Augmentation Index in Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Fraction of missed pulse wave analysis [ Time Frame: Meaured two times with an interval of one week ] [ Designated as safety issue: No ]
    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:
  • Reproducibility of pulse wave analysis parameters [ Time Frame: Measured two times with an interval of one week ] [ Designated as safety issue: No ]
    Reproducibility of pulse wave velocity, Central systoloc blood pressure and central augmentation index for 24 hour, day and night


Other Outcome Measures:
  • Diurnal variation of brachial blood pressure, central blood pressure and pulse wave velocity [ Time Frame: Measured two times with an interval of one week ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 20
Study Start Date: September 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01812811

Contacts
Contact: Klavs W Hansen, MD, Dr.MED. 004527627618 klavhans@rm.dk
Contact: Christoffer Krogager, MD 004531550777 ckrogager@gmail.com

Locations
Denmark
Medical department, Diagnostic Center, Regional Hospital Silkeborg Recruiting
Silkeborg, Denmark, 8600
Contact: Klavs W Hansen, MD. Dr.med.     004527627618     klavhans@rm.dk    
Contact: Christoffer Krogager, MD     004531550777     ckrogager@gmail.com    
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
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01812811     History of Changes
Other Study ID Numbers: 35522
Study First Received: March 14, 2013
Last Updated: March 14, 2013
Health Authority: Denmark: Ethics Committee

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

ClinicalTrials.gov processed this record on May 21, 2013