NCT01812811

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

10 months

First QC Date

March 14, 2013

Last Update Submit

December 10, 2013

Conditions

Type 2 Diabetes

Keywords

pulse wave analysispulse wave velocityArteriograph24Ambulatorydiabetesreproducibilitydiurnal variation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Reproducibility of pulse wave analysis parameters

    Measured two times with an interval of one week

Other Outcomes (1)

  • Diurnal variation of brachial blood pressure, central blood pressure and pulse wave velocity

    Measured two times with an interval of one week

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Type 2 diabetes patients recruited from out patient clinic

You may qualify if:

  • Type 2 diabetes

You may not qualify if:

  • Atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical department, Diagnostic Center, Regional Hospital Silkeborg

Silkeborg, Silkeborg, 8600, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Klavs W Hansen, MD, dr.med.

    Medical department, Diagnostic Center, Regional Hospital Silkeborg, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2013

First Posted

March 18, 2013

Study Start

September 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations

DK(1)