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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01812811
• Other study ID #: 35522
• Status: Completed
• Phase: N/A
• First received: March 14, 2013
• Last updated: December 10, 2013
• Start date: September 2012
• Est. completion date: July 2013

Study information

• Verified date: December 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes

Exclusion Criteria:

• Atrial fibrillation

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Locations

Country	Name	City	State
Denmark	Medical department, Diagnostic Center, Regional Hospital Silkeborg	Silkeborg

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Regionshospitalet Silkeborg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diurnal variation of brachial blood pressure, central blood pressure and pulse wave velocity	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	No
Primary	Fraction of missed pulse wave analysis	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	No
Secondary	Reproducibility of pulse wave analysis parameters	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	No