Type 2 DiabetesNCT01812811
Twentyfour Ambulatory Pulse Wave Velocity and Central Augmentation Index in Type 2 Diabetes
An observational study of Type 2 Diabetes, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2012to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 diabetes patients recruited from out patient clinic
Who may be able to join
- Type 2 diabetes
Who cannot join
- Atrial fibrillation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medical department, Diagnostic Center, Regional Hospital Silkeborg
Silkeborg, Silkeborg, 8600
About this study
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Keywords
- pulse wave analysis, pulse wave velocity, Arteriograph24, Ambulatory, diabetes, reproducibility, diurnal variation
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Meaured two times with an interval of one week
Secondary outcomes (1)
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: Measured two times with an interval of one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startSep 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Regionshospitalet Silkeborg
- Responsible party
- Sponsor
- Investigators
- Klavs W Hansen, MD, dr.med., Principal investigator, Medical department, Diagnostic Center, Regional Hospital Silkeborg, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812811
- Sponsor's protocol ID
- 35522
- Status last verified
- Dec 2013
- First submitted
- 14 Mar 2013
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twentyfour Ambulatory Pulse Wave Velocity and Central Augmentation Index in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01812811
- Acronym / sponsor ID
- 35522
- Conditions
- Type 2 Diabetes
- Keywords
- pulse wave analysis, pulse wave velocity, Arteriograph24, Ambulatory, diabetes, reproducibility, diurnal variation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Regionshospitalet Silkeborg
- Study start
- Sep 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 18 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetes patients recruited from out patient clinic
Key inclusion criteria (1 listed)
- Type 2 diabetes
Key exclusion criteria (1 listed)
- Atrial fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Reproducibility of pulse wave analysis parameters
Time frame: Measured two times with an interval of one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klavs W Hansen, MD, dr.med. principal investigator
Medical department, Diagnostic Center, Regional Hospital Silkeborg, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fraction of missed pulse wave analysis (time frame: Meaured two times with an interval of one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2013.