Diabetes Mellitus, Type 2IMPRESSNCT01538290
Validating Non-invasive Measurements of Central Blood Pressure in Type 2 Diabetic Patients
An observational study of Diabetes Mellitus, Type 2 and Blood Pressure, run by University of Aarhus at 1 site in Denmark.
Trial summary
The investigators want to validate two non-invasive devices for the determination of central blood pressure, i.e. blood pressure in the aorta (artery leaving the heart). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Blood Pressure
- How many people
- 34 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2011to Mar 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with type 2 diabetes mellitus referred to elective coronary angiography.
Who may be able to join
- Diabetes Mellitus, Type 2
- Age above 18 years
Who cannot join
- Atrial fibrillation or other cardiac arrhythmia
- known stenosis of aorta or arteria subclavia/brachialis
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital, Skejby, Department of Cardiology
Aarhus, 8000
About this study
Official title: Validating Non-invasive Measurements of Central Blood Pressure in Type 2 Diabetic
The investigators want to validate two non-invasive devices for the determination of central blood pressure, i.e. blood pressure in the aorta (artery leaving the heart).
- Conditions
- Diabetes Mellitus, Type 2, Blood Pressure
- Keywords
- Calibration, Validation, Transfer function, SphygmoCor, Arteriograph
- Medical subject headings
- Diabetes Mellitus, Type 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startNov 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans Erik Bøtker, MD,Professor, Study director, Aarhus University Hospital, Skejby, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538290
- Sponsor's protocol ID
- M-20110166
- Acronym
- IMPRESS
- Status last verified
- Jun 2012
- First submitted
- 20 Feb 2012
- Last updated
- 12 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Laugesen E, Rossen NB, Peters CD, Maeng M, Ebbehoj E, Knudsen ST, Hansen KW, Botker HE, Poulsen PL. Assessment of central blood pressure in patients with type 2 diabetes: a comparison between SphygmoCor and invasively measured values. Am J Hypertens. 2014 Feb;27(2):169-76. doi: 10.1093/ajh/hpt195. Epub 2013 Dec 4.
PubMed 24304654Rossen NB, Laugesen E, Peters CD, Ebbehoj E, Knudsen ST, Poulsen PL, Botker HE, Hansen KW. Invasive validation of arteriograph estimates of central blood pressure in patients with type 2 diabetes. Am J Hypertens. 2014 May;27(5):674-9. doi: 10.1093/ajh/hpt162. Epub 2013 Aug 31.
PubMed 23996499
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating Non-invasive Measurements of Central Blood Pressure in Type 2 Diabetic
- ClinicalTrials.gov ID
- NCT01538290
- Acronym / sponsor ID
- IMPRESS / M-20110166
- Conditions
- Diabetes Mellitus, Type 2, Blood Pressure
- Keywords
- Calibration, Validation, Transfer function, SphygmoCor, Arteriograph
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 24 Feb 2012 (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 investigators want to validate two non-invasive devices for the determination of central blood pressure, i.e. blood pressure in the aorta (artery leaving the heart).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with type 2 diabetes mellitus referred to elective coronary angiography.
Key inclusion criteria (2 listed)
- Diabetes Mellitus, Type 2
- Age above 18 years
Key exclusion criteria (2 listed)
- Atrial fibrillation or other cardiac arrhythmia
- known stenosis of aorta or arteria subclavia/brachialis
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
Not reported in the source record.
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 12 Jun 2012.
- Derived from this study: PubMed 24304654Laugesen E, Rossen NB, Peters CD, Maeng M, Ebbehoj E, Knudsen ST, Hansen KW, Botker HE, Poulsen PL. Assessment of central blood pressure in patients with type 2 diabetes: a comparison between SphygmoCor and invasively measured values. Am J Hypertens. 2014 Feb;27(2):169-76. doi: 10.1093/ajh/hpt195. Epub 2013 Dec 4.
- Derived from this study: PubMed 23996499Rossen NB, Laugesen E, Peters CD, Ebbehoj E, Knudsen ST, Poulsen PL, Botker HE, Hansen KW. Invasive validation of arteriograph estimates of central blood pressure in patients with type 2 diabetes. Am J Hypertens. 2014 May;27(5):674-9. doi: 10.1093/ajh/hpt162. Epub 2013 Aug 31.
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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.
Hans Erik Bøtker, MD,Professor study director
Aarhus University Hospital, Skejby, Department of Cardiology
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 Diabetes Mellitus, Type 2 and Blood Pressure, 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 2 inclusion and 2 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 12 Jun 2012. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01538290, which also lists 2 linked publications.
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 12 Jun 2012.