Aortic StiffnessNCT02663791
Alcohol Consumption and Arterial Stiffness: A Longitudinal Study of Pulse Wave Velocity in the Whitehall II Cohort
An observational study of Aortic Stiffness, run by University College, London at 1 site in United Kingdom.
Trial summary
Arterial stiffness is an important marker of cardiovascular health. Recent evidence from cross-sectional research has suggested it is associated with alcohol consumption. Research that employs a longitudinal perspective may be better equipped to evaluate the nature of this relationship and in particular to determine… Read more about this study
- Who is it for?
- Ages 34 to 100 years
- Conditions the study is for
- Aortic Stiffness
- How many people
- 10,308 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Jun 2016
- 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 34 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data will be drawn from the Whitehall II cohort study database. This incorporates longitudinal assessments of 6,895 male (67%) and 3,413 female British civil servants, originally recruited between 1985 and 1988. The overall age range was 34 to 56 years. Of these, 897 were excluded due to having a history of cardiovascular disease. Clinical assessments were repeated at 4-to-5 year intervals. PWV measurement was introduced to the protocol at phase 9, with assessments taking place during 2008 and 2009. 3,869 of the sample participants had a successful PWV assessment during this time. Follow-up testing took place at phase 11, during 2012 and 2013. Of the participants who underwent a PWV assessment at phase 9, 3,130 also had a successful PWV assessment at phase 11. This group included 2,350 males (75%) and 780 females.
Who may be able to join
- Participated in Whitehall II cohort study
- Reported alcohol consumption on a minimum of one occasion between phase 1 and phase 9 of the Whitehall II cohort study
Who cannot join
- Left Whitehall II cohort study prior to phase 9 or did not participate in PWV assessment at Phase 9
- Had history of coronary heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Arterial stiffness is an important marker of cardiovascular health. Recent evidence from cross-sectional research has suggested it is associated with alcohol consumption. Research that employs a longitudinal perspective may be better equipped to evaluate the nature of this relationship and in particular to determine whether alcohol consumption is linked to the progression of arterial stiffness over time. The current study will consequently implement a longitudinal cohort design to evaluate the association between long-term alcohol consumption patterns and changes in arterial stiffness. Data will be drawn from the Whitehall II cohort study of British civil servants, in which participants completed repeat pulse wave velocity (PWV) assessments of arterial stiffness across a four-to-five year interval. Repeat measurements of volume of alcohol intake were also recorded for participants, extending back across more than two decades. Intake will be categorised in such a way as to distinguish between different alcohol consumer types, including non-drinkers and former drinkers. Linear mixed effects models will be used with adjustment for potential confounds, such as age, diabetes, mean arterial pressure and heart rate. Results from the modelling work will illustrate the extent and form of the association between alcohol intake and PWV. This work will provide useful insights into the role that alcohol intake plays in the longitudinal progression of an important cardiac marker, and it will have implications for our understanding of alcohol's relationship to cardiovascular health in the general population.
Read the detailed description
Arterial stiffness occurs where the vessel wall lacks elasticity. It is known to be independently associated with both cardiovascular morbidity and mortality, such that it can act as a surrogate end point for studies of cardiovascular disease. Pulse wave velocity (PWV) is an index of this stiffness and has been described as its 'gold standard' measurement.
A number of other clinical factors have been found to show meaningful association with PWV, including heart rate and mean arterial pressure. These findings have highlighted the need for studies of new potential determinants of PWV to account for the potentially confounding influence of these known factors. Additional demographic and lifestyle characteristics have also been shown to act as moderators of PWV. In particular, research has demonstrated that PWV increases with age, and this stiffness is consequently deemed an indicator of vascular ageing.
Alcohol intake is another lifestyle characteristic that has been considered as a potential factor in the loss of arterial elasticity. Evidence to date suggests that a J-shaped association may exist between such intake and PWV, but this work has mostly relied on cross-sectional data or looked at short-term intake patterns only. By adopting a longitudinal perspective, further insight may be garnered into this important epidemiological issue. Consequently, the new study herein proposed will address this research need and investigate how different patterns of alcohol consumption relate to arterial stiffness and to the progression of this stiffness over time. The primary objectives of this study are to (1) examine whether long-term patterns of alcohol consumption are independently associated with a baseline assessment of carotid-femoral PWV and (2) whether alcohol intake is likewise associated with longitudinal changes in this important cardiovascular marker.
Longitudinal alcohol exposure will be determined from reported consumption at phases 1 (1985-1988) through 9 (2007-2009) of the Whitehall II Cohort Study and categorised according to the latest UK recommendations on alcohol intake limits. These guidelines define moderate consumption as weekly ethanol intake volumes of 112g or under for both males and females. As alcohol consumption is recorded in UK units in the Whitehall II database, conversion will be performed using the standard ratio of 1 unit to 8 grams of ethanol prior to categorisation. The subsequent categorisation will draw distinctions between non-drinkers and former drinkers, as well as between moderate and heavy consumers. Those with unstable patterns of consumption will also be identified as there is emerging evidence that such consumers may have a different cardiovascular risk profile compared to consumers with more longitudinally consistent intake patterns.
Demographic and clinical characteristics will be investigated to provide context for the subsequent inferential analyses. As research has also suggested that participant sex can moderate the relationship between alcohol and PWV, this will be tested in the current analysis (through preliminary modelling that includes sex as part of an interaction term with level of alcohol consumption). If this moderation effect is replicated, then our core result reporting will be stratified according to sex.
Linear mixed effects models will then be used to examine the effect of long-term alcohol consumption on PWV and its effect on subsequent longitudinal changes in this cardiovascular marker. This modelling approach is particularly suited to analysing the complex data structure under investigation, including the correlation across individual participants' paired measurements. A detailed analytic protocol is available upon request.
Supplementary linear mixed effects modelling will also be performed to look at the association between short-term alcohol consumption patterns and PWV. This will employ the same modelling strategy as used in the primary analysis above, with the categorisation of consumption utilising reported intake at the most recent assessment phase only. This supplementary analysis will offer additional context for the findings of the primary analysis and provide further detail on the relationship that different forms of alcohol consumption have with arterial stiffness.
Through this comprehensive and detailed analysis, it is hoped that new insights on this important issue of cardiovascular health will be obtained.
- Conditions
- Aortic Stiffness
- Keywords
- Alcohol, Aortic stiffness, Arterial stiffness, Pulse wave velocity, Longitudinal
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Carotid-Femoral Pulse Wave Velocity
A baseline carotid-femoral pulse wave velocity (PWV) assessment occurred at phase 9 (each participant attended an assessment day during 2008 or 2009) of the Whitehall II cohort study. Up to 3 PWV measurements were performed during this assessment, and where a participant underwent multiple measurements, the mean of these will be calculated for that participant and used as their baseline PWV measurement.
Measured: 1 day
Change from Baseline Carotid-Femoral Pulse Wave Velocity at Follow-Up
Change in carotid-femoral PWV between the baseline and follow-up PWV assessments will be investigated. The follow-up PWV assessment occurred at phase 11 (2012-2013) of the Whitehall II cohort study. Up to 3 PWV measurements were again performed during this assessment, and where a participant underwent multiple measurements, the mean of these will be calculated for that participant and used as their follow-up PWV measurement.
Measured: 4 to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Aortic StiffnessStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Prospective
- Enrolment
- 10,308 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, Alcohol Research UK
- Responsible party
- Principal investigator, Dara O'Neill, University College, London
- Investigators
- D O'Neill, PhD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663791
- Sponsor's protocol ID
- Whitehall II - Alcohol PWV 01
- Status last verified
- May 2023
- First submitted
- 18 Jan 2016
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Researchers can request access to anonymised data: http://www.ucl.ac.uk/whitehallII/data-sharing
Publications
Marmot M, Brunner E. Cohort Profile: the Whitehall II study. Int J Epidemiol. 2005 Apr;34(2):251-6. doi: 10.1093/ije/dyh372. Epub 2004 Dec 2. No abstract available.
PubMed 15576467Cavalcante JL, Lima JA, Redheuil A, Al-Mallah MH. Aortic stiffness: current understanding and future directions. J Am Coll Cardiol. 2011 Apr 5;57(14):1511-22. doi: 10.1016/j.jacc.2010.12.017.
PubMed 21453829Vlachopoulos C, Aznaouridis K, Stefanadis C. Prediction of cardiovascular events and all-cause mortality with arterial stiffness: a systematic review and meta-analysis. J Am Coll Cardiol. 2010 Mar 30;55(13):1318-27. doi: 10.1016/j.jacc.2009.10.061.
PubMed 20338492Cecelja M, Chowienczyk P. Role of arterial stiffness in cardiovascular disease. JRSM Cardiovasc Dis. 2012 Jul 31;1(4):cvd.2012.012016. doi: 10.1258/cvd.2012.012016.
PubMed 24175067Cecelja M, Chowienczyk P. Dissociation of aortic pulse wave velocity with risk factors for cardiovascular disease other than hypertension: a systematic review. Hypertension. 2009 Dec;54(6):1328-36. doi: 10.1161/HYPERTENSIONAHA.109.137653. Epub 2009 Nov 2.
PubMed 19884567Matsumoto C, Tomiyama H, Yamada J, Yoshida M, Shiina K, Nagata M, Yamashina A. Association of blood pressure levels with the effects of alcohol intake on the vasculature in Japanese men. Hypertens Res. 2009 Feb;32(2):127-32. doi: 10.1038/hr.2008.23. Epub 2009 Jan 16.
PubMed 19262471Beilin L. Alcohol and cardiovascular disease: possible protection via effects on aortic stiffness. J Hypertens. 2005 Apr;23(4):703-5. doi: 10.1097/01.hjh.0000163133.62020.98. No abstract available.
PubMed 15775769Sasaki S, Yoshioka E, Saijo Y, Kita T, Okada E, Tamakoshi A, Kishi R. Relation between alcohol consumption and arterial stiffness: A cross-sectional study of middle-aged Japanese women and men. Alcohol. 2013 Dec;47(8):643-9. doi: 10.1016/j.alcohol.2013.10.003. Epub 2013 Oct 17.
PubMed 24239150Laurent S, Cockcroft J, Van Bortel L, Boutouyrie P, Giannattasio C, Hayoz D, Pannier B, Vlachopoulos C, Wilkinson I, Struijker-Boudier H; European Network for Non-invasive Investigation of Large Arteries. Expert consensus document on arterial stiffness: methodological issues and clinical applications. Eur Heart J. 2006 Nov;27(21):2588-605. doi: 10.1093/eurheartj/ehl254. Epub 2006 Sep 25.
PubMed 17000623O'Neill D, Britton A, Brunner EJ, Bell S. Twenty-Five-Year Alcohol Consumption Trajectories and Their Association With Arterial Aging: A Prospective Cohort Study. J Am Heart Assoc. 2017 Feb 20;6(2):e005288. doi: 10.1161/JAHA.116.005288.
PubMed 28219925
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Consumption and Arterial Stiffness: A Longitudinal Study of Pulse Wave Velocity in the Whitehall II Cohort
- ClinicalTrials.gov ID
- NCT02663791
- Acronym / sponsor ID
- Whitehall II - Alcohol PWV 01
- Conditions
- Aortic Stiffness
- Keywords
- Alcohol, Aortic stiffness, Arterial stiffness, Pulse wave velocity, Longitudinal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,308 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Medical Research Council, Alcohol Research UK
- Study start
- Jan 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 26 Jan 2016 (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.
Arterial stiffness is an important marker of cardiovascular health. Recent evidence from cross-sectional research has suggested it is associated with alcohol consumption. Research that employs a longitudinal perspective may be better equipped to evaluate the nature of this relationship and in particular to determine whether alcohol consumption is linked to the progression of arterial stiffness over time. The current study will consequently implement a longitudinal cohort design to evaluate the association between long-term alcohol consumption patterns and changes in arterial stiffness. Data will be drawn from the Whitehall II cohort study of British civil servants, in which participants completed repeat pulse wave velocity (PWV) assessments of arterial stiffness across a four-to-five year interval. Repeat measurements of volume of alcohol intake were also recorded for participants, extending back across more than two decades. Intake will be categorised in such a way as to distinguish between different alcohol consumer types, including non-drinkers and former drinkers. Linear mixed effects models will be used with adjustment for potential confounds, such as age, diabetes, mean arterial pressure and heart rate. Results from the modelling work will illustrate the extent and form of the association between alcohol intake and PWV. This work will provide useful insights into the role that alcohol intake plays in the longitudinal progression of an important cardiac marker, and it will have implications for our understanding of alcohol's relationship to cardiovascular health in the general population.
Detailed description
Arterial stiffness occurs where the vessel wall lacks elasticity. It is known to be independently associated with both cardiovascular morbidity and mortality, such that it can act as a surrogate end point for studies of cardiovascular disease. Pulse wave velocity (PWV) is an index of this stiffness and has been described as its 'gold standard' measurement.
A number of other clinical factors have been found to show meaningful association with PWV, including heart rate and mean arterial pressure. These findings have highlighted the need for studies of new potential determinants of PWV to account for the potentially confounding influence of these known factors. Additional demographic and lifestyle characteristics have also been shown to act as moderators of PWV. In particular, research has demonstrated that PWV increases with age, and this stiffness is consequently deemed an indicator of vascular ageing.
Alcohol intake is another lifestyle characteristic that has been considered as a potential factor in the loss of arterial elasticity. Evidence to date suggests that a J-shaped association may exist between such intake and PWV, but this work has mostly relied on cross-sectional data or looked at short-term intake patterns only. By adopting a longitudinal perspective, further insight may be garnered into this important epidemiological issue. Consequently, the new study herein proposed will address this research need and investigate how different patterns of alcohol consumption relate to arterial stiffness and to the progression of this stiffness over time. The primary objectives of this study are to (1) examine whether long-term patterns of alcohol consumption are independently associated with a baseline assessment of carotid-femoral PWV and (2) whether alcohol intake is likewise associated with longitudinal changes in this important cardiovascular marker.
Longitudinal alcohol exposure will be determined from reported consumption at phases 1 (1985-1988) through 9 (2007-2009) of the Whitehall II Cohort Study and categorised according to the latest UK recommendations on alcohol intake limits. These guidelines define moderate consumption as weekly ethanol intake volumes of 112g or under for both males and females. As alcohol consumption is recorded in UK units in the Whitehall II database, conversion will be performed using the standard ratio of 1 unit to 8 grams of ethanol prior to categorisation. The subsequent categorisation will draw distinctions between non-drinkers and former drinkers, as well as between moderate and heavy consumers. Those with unstable patterns of consumption will also be identified as there is emerging evidence that such consumers may have a different cardiovascular risk profile compared to consumers with more longitudinally consistent intake patterns.
Demographic and clinical characteristics will be investigated to provide context for the subsequent inferential analyses. As research has also suggested that participant sex can moderate the relationship between alcohol and PWV, this will be tested in the current analysis (through preliminary modelling that includes sex as part of an interaction term with level of alcohol consumption). If this moderation effect is replicated, then our core result reporting will be stratified according to sex.
Linear mixed effects models will then be used to examine the effect of long-term alcohol consumption on PWV and its effect on subsequent longitudinal changes in this cardiovascular marker. This modelling approach is particularly suited to analysing the complex data structure under investigation, including the correlation across individual participants' paired measurements. A detailed analytic protocol is available upon request.
Supplementary linear mixed effects modelling will also be performed to look at the association between short-term alcohol consumption patterns and PWV. This will employ the same modelling strategy as used in the primary analysis above, with the categorisation of consumption utilising reported intake at the most recent assessment phase only. This supplementary analysis will offer additional context for the findings of the primary analysis and provide further detail on the relationship that different forms of alcohol consumption have with arterial stiffness.
Through this comprehensive and detailed analysis, it is hoped that new insights on this important issue of cardiovascular health will be obtained.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 34 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data will be drawn from the Whitehall II cohort study database. This incorporates longitudinal assessments of 6,895 male (67%) and 3,413 female British civil servants, originally recruited between 1985 and 1988. The overall age range was 34 to 56 years. Of these, 897 were excluded due to having a history of cardiovascular disease. Clinical assessments were repeated at 4-to-5 year intervals. PWV measurement was introduced to the protocol at phase 9, with assessments taking place during 2008 and 2009. 3,869 of the sample participants had a successful PWV assessment during this time. Follow-up testing took place at phase 11, during 2012 and 2013. Of the participants who underwent a PWV assessment at phase 9, 3,130 also had a successful PWV assessment at phase 11. This group included 2,350 males (75%) and 780 females.
Key inclusion criteria (2 listed)
- Participated in Whitehall II cohort study
- Reported alcohol consumption on a minimum of one occasion between phase 1 and phase 9 of the Whitehall II cohort study
Key exclusion criteria (2 listed)
- Left Whitehall II cohort study prior to phase 9 or did not participate in PWV assessment at Phase 9
- Had history of coronary heart disease
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
Baseline Carotid-Femoral Pulse Wave Velocity
Time frame: 1 day
A baseline carotid-femoral pulse wave velocity (PWV) assessment occurred at phase 9 (each participant attended an assessment day during 2008 or 2009) of the Whitehall II cohort study. Up to 3 PWV measurements were performed during this assessment, and where a participant underwent multiple measurements, the mean of these will be calculated for that participant and used as their baseline PWV measurement.
Change from Baseline Carotid-Femoral Pulse Wave Velocity at Follow-Up
Time frame: 4 to 5 years
Change in carotid-femoral PWV between the baseline and follow-up PWV assessments will be investigated. The follow-up PWV assessment occurred at phase 11 (2012-2013) of the Whitehall II cohort study. Up to 3 PWV measurements were again performed during this assessment, and where a participant underwent multiple measurements, the mean of these will be calculated for that participant and used as their follow-up PWV measurement.
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 May 2023.
- Background: PubMed 15576467Marmot M, Brunner E. Cohort Profile: the Whitehall II study. Int J Epidemiol. 2005 Apr;34(2):251-6. doi: 10.1093/ije/dyh372. Epub 2004 Dec 2. No abstract available.
- Background: PubMed 21453829Cavalcante JL, Lima JA, Redheuil A, Al-Mallah MH. Aortic stiffness: current understanding and future directions. J Am Coll Cardiol. 2011 Apr 5;57(14):1511-22. doi: 10.1016/j.jacc.2010.12.017.
- Background: PubMed 20338492Vlachopoulos C, Aznaouridis K, Stefanadis C. Prediction of cardiovascular events and all-cause mortality with arterial stiffness: a systematic review and meta-analysis. J Am Coll Cardiol. 2010 Mar 30;55(13):1318-27. doi: 10.1016/j.jacc.2009.10.061.
- Background: PubMed 24175067Cecelja M, Chowienczyk P. Role of arterial stiffness in cardiovascular disease. JRSM Cardiovasc Dis. 2012 Jul 31;1(4):cvd.2012.012016. doi: 10.1258/cvd.2012.012016.
- Background: PubMed 19884567Cecelja M, Chowienczyk P. Dissociation of aortic pulse wave velocity with risk factors for cardiovascular disease other than hypertension: a systematic review. Hypertension. 2009 Dec;54(6):1328-36. doi: 10.1161/HYPERTENSIONAHA.109.137653. Epub 2009 Nov 2.
- Background: PubMed 19262471Matsumoto C, Tomiyama H, Yamada J, Yoshida M, Shiina K, Nagata M, Yamashina A. Association of blood pressure levels with the effects of alcohol intake on the vasculature in Japanese men. Hypertens Res. 2009 Feb;32(2):127-32. doi: 10.1038/hr.2008.23. Epub 2009 Jan 16.
- Background: PubMed 15775769Beilin L. Alcohol and cardiovascular disease: possible protection via effects on aortic stiffness. J Hypertens. 2005 Apr;23(4):703-5. doi: 10.1097/01.hjh.0000163133.62020.98. No abstract available.
- Background: PubMed 24239150Sasaki S, Yoshioka E, Saijo Y, Kita T, Okada E, Tamakoshi A, Kishi R. Relation between alcohol consumption and arterial stiffness: A cross-sectional study of middle-aged Japanese women and men. Alcohol. 2013 Dec;47(8):643-9. doi: 10.1016/j.alcohol.2013.10.003. Epub 2013 Oct 17.
- Background: PubMed 17000623Laurent S, Cockcroft J, Van Bortel L, Boutouyrie P, Giannattasio C, Hayoz D, Pannier B, Vlachopoulos C, Wilkinson I, Struijker-Boudier H; European Network for Non-invasive Investigation of Large Arteries. Expert consensus document on arterial stiffness: methodological issues and clinical applications. Eur Heart J. 2006 Nov;27(21):2588-605. doi: 10.1093/eurheartj/ehl254. Epub 2006 Sep 25.
- Derived from this study: PubMed 28219925O'Neill D, Britton A, Brunner EJ, Bell S. Twenty-Five-Year Alcohol Consumption Trajectories and Their Association With Arterial Aging: A Prospective Cohort Study. J Am Heart Assoc. 2017 Feb 20;6(2):e005288. doi: 10.1161/JAHA.116.005288.
- UCL Research Department of Epidemiology \& Public HealthLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Researchers can request access to anonymised data: http://www.ucl.ac.uk/whitehallII/data-sharing
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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.
D O'Neill, PhD principal investigator
University College, London
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 Aortic Stiffness, run by University College, London at 1 site in United Kingdom.
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 11 May 2023. 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 United Kingdom. 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?
Baseline Carotid-Femoral Pulse Wave Velocity (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02663791, which also lists 10 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 11 May 2023.