Diabetes Mellitus Type IINCT02028091

Diabetes Mellitus - A Diagnosis Trial by Means of Non Invasive Measurements

An observational study of Diabetes Mellitus Type II, run by Medical University of Vienna at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Vascular damage caused by diabetes mellitus, cigarette smoking, age and arterial hypertension theoretically changes pulse wave velocity. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus Type II
How many people: 100 participants
Where: 1 siteAustria
Study dates: Sep 2012to Jan 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: 50 patients over 18 years with diagnosed type II diabetes mellitus are included into the diabetes group. 50 healthy patients with no known or diagnosed diabetes mellitus or damage of the vessels are included into the non diabetes group.

Who may be able to join

Patients over 18 years

Who cannot join

Diabetic foot gangrene
No possibility of pulse wave velocitiy measurement on the finger or toe

Trial locations and contacts

1 site in 1 country.

Austria1 site

Medical University of Vienna
Vienna, State of Vienna, 1090

Other trials in Austria

About this study

Vascular damage caused by diabetes mellitus, cigarette smoking, age and arterial hypertension theoretically changes pulse wave velocity.

Read the detailed description

Diabetes mellitus related vascular alterations are associated with an increased risk of hypertonia, atherosclerosis, neuropathy, diabetic retinopathy, and further more.

Increased vascular rigidity, which is based on the increased stiffness of vessels caused by vascular damage leads to an increase of pulse wave velocity. This assumption is based on the Moens-Korteweg-equation which is calculated using the modus of arterial vessel elasticity, arterial vessel wall thickness, the arterial radius and blood viscosity.

Conditions: Diabetes Mellitus Type II
Keywords: Pulse walve arrival time differences
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02028091
Study group	Role	What they receive
Diabetes mellitus		All patients over 18 years with diagnosed diabetes mellitus type II.
Non Diabetic		Patients over 18 years with no known diabetes mellitus or other known/diagnosed vascular diseases.

What is being measured

The primary outcome is the main question the study is designed to answer.

Pulse wave arrival time difference between finger and toe, duration of diabetes
The pulse wave is recorded by plethysmography using a pulse-oximeter and a continuous noninvasive arterial blood pressure measurement (CNAP-500) device, both on the finger and toe. The time between these 4 recorded waves is then calculated. The influence of age, duration of known arterial hypertension, cigarette smoking (pack-years) and diabetes mellitus.
Measured: 1 Minute data recording of the pulse waves at four sites.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2012Jan 2013

First posted6 Jan 2014 (estimated)
Study startSep 2012
Primary completionJan 2013
Study completionJan 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus Type IIStudies of the same condition, open and under way.
More trials run by Medical University of ViennaThe 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: Case-control
Time perspective: Prospective
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02028091
Sponsor's protocol ID: 1242/2012
Status last verified: Jan 2014
First submitted: 3 Jan 2014
Last updated: 7 Jan 2014
Results posted: No
Data monitoring committee: No

Publications

Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998 Jul;15(7):539-53. doi: 10.1002/(SICI)1096-9136(199807)15:73.0.CO;2-S.
PubMed 9686693
Babchenko A, Davidson E, Adler D, Ginosar Y, Kurz V, Nitzan M. Increase in pulse transit time to the foot after epidural anaesthesia treatment. Med Biol Eng Comput. 2000 Nov;38(6):674-9. doi: 10.1007/BF02344874.
PubMed 11217886
Chen YT, Chiayg CY, Wang MC, Tsai WC, Wu HT, Liu CC. Serial changes of pulse wave velocity and correlations with hemodynamic parameters during general anesthesia. Acta Anaesthesiol Taiwan. 2006 Dec;44(4):193-8.
PubMed 17233362
Chowienczyk PJ, Kelly RP, MacCallum H, Millasseau SC, Andersson TL, Gosling RG, Ritter JM, Anggard EE. Photoplethysmographic assessment of pulse wave reflection: blunted response to endothelium-dependent beta2-adrenergic vasodilation in type II diabetes mellitus. J Am Coll Cardiol. 1999 Dec;34(7):2007-14. doi: 10.1016/s0735-1097(99)00441-6.
PubMed 10588217
Foo JY, Wilson SJ, Williams G, Harris MA, Cooper D. Age-related factors that confound peripheral pulse timing characteristics in Caucasian children. J Hum Hypertens. 2005 Jun;19(6):463-6. doi: 10.1038/sj.jhh.1001846.
PubMed 15729376
Dickersin K, Min YI, Meinert CL. Factors influencing publication of research results. Follow-up of applications submitted to two institutional review boards. JAMA. 1992 Jan 15;267(3):374-8.
PubMed 1727960
Foo JY, Wilson SJ, Williams G, Harris MA, Cooper D. Pulse transit time as a derived noninvasive mean to monitor arterial distensibility changes in children. J Hum Hypertens. 2005 Sep;19(9):723-9. doi: 10.1038/sj.jhh.1001891.
PubMed 15920454
Foo JY, Lim CS. Pulse transit time as an indirect marker for variations in cardiovascular related reactivity. Technol Health Care. 2006;14(2):97-108.
PubMed 16720953
Harris MI. Undiagnosed NIDDM: clinical and public health issues. Diabetes Care. 1993 Apr;16(4):642-52. doi: 10.2337/diacare.16.4.642. No abstract available.
PubMed 8462395
Jaryal AK, Selvaraj N, Santhosh J, Anand S, Deepak KK. Monitoring of cardiovascular reactivity to cold stress using digital volume pulse characteristics in health and diabetes. J Clin Monit Comput. 2009 Apr;23(2):123-30. doi: 10.1007/s10877-009-9174-z. Epub 2009 Mar 24.
PubMed 19308667
Kinsella SM, Whitwam JG, Spencer JA. Aortic compression by the uterus: identification with the Finapres digital arterial pressure instrument. Br J Obstet Gynaecol. 1990 Aug;97(8):700-5. doi: 10.1111/j.1471-0528.1990.tb16242.x.
PubMed 2400747
Kelly RP, Millasseau SC, Ritter JM, Chowienczyk PJ. Vasoactive drugs influence aortic augmentation index independently of pulse-wave velocity in healthy men. Hypertension. 2001 Jun;37(6):1429-33. doi: 10.1161/01.hyp.37.6.1429.
PubMed 11408390

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus Type II trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Diabetes Mellitus - A Diagnosis Trial by Means of Non Invasive Measurements
ClinicalTrials.gov ID: NCT02028091
Acronym / sponsor ID: 1242/2012
Conditions: Diabetes Mellitus Type II
Keywords: Pulse walve arrival time differences
Study type: Observational
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Medical University of ViennaUniversity, hospital or other
Study start: Sep 2012
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 6 Jan 2014 (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.

Vascular damage caused by diabetes mellitus, cigarette smoking, age and arterial hypertension theoretically changes pulse wave velocity.

Detailed description

Diabetes mellitus related vascular alterations are associated with an increased risk of hypertonia, atherosclerosis, neuropathy, diabetic retinopathy, and further more.

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Diabetes mellitus	–	–All patients over 18 years with diagnosed diabetes mellitus type II.
Non Diabetic	–	–Patients over 18 years with no known diabetes mellitus or other known/diagnosed vascular diseases.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 50 patients over 18 years with diagnosed type II diabetes mellitus are included into the diabetes group. 50 healthy patients with no known or diagnosed diabetes mellitus or damage of the vessels are included into the non diabetes group.

Key inclusion criteria (1 listed)

Patients over 18 years

Key exclusion criteria (2 listed)

Diabetic foot gangrene
No possibility of pulse wave velocitiy measurement on the finger or toe

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

Pulse wave arrival time difference between finger and toe, duration of diabetes
Time frame: 1 Minute data recording of the pulse waves at four sites.
The pulse wave is recorded by plethysmography using a pulse-oximeter and a continuous noninvasive arterial blood pressure measurement (CNAP-500) device, both on the finger and toe. The time between these 4 recorded waves is then calculated. The influence of age, duration of known arterial hypertension, cigarette smoking (pack-years) and diabetes mellitus.

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 7 Jan 2014.
Background: PubMed 9686693Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998 Jul;15(7):539-53. doi: 10.1002/(SICI)1096-9136(199807)15:73.0.CO;2-S.
Background: PubMed 11217886Babchenko A, Davidson E, Adler D, Ginosar Y, Kurz V, Nitzan M. Increase in pulse transit time to the foot after epidural anaesthesia treatment. Med Biol Eng Comput. 2000 Nov;38(6):674-9. doi: 10.1007/BF02344874.
Background: PubMed 17233362Chen YT, Chiayg CY, Wang MC, Tsai WC, Wu HT, Liu CC. Serial changes of pulse wave velocity and correlations with hemodynamic parameters during general anesthesia. Acta Anaesthesiol Taiwan. 2006 Dec;44(4):193-8.
Background: PubMed 10588217Chowienczyk PJ, Kelly RP, MacCallum H, Millasseau SC, Andersson TL, Gosling RG, Ritter JM, Anggard EE. Photoplethysmographic assessment of pulse wave reflection: blunted response to endothelium-dependent beta2-adrenergic vasodilation in type II diabetes mellitus. J Am Coll Cardiol. 1999 Dec;34(7):2007-14. doi: 10.1016/s0735-1097(99)00441-6.
Background: PubMed 15729376Foo JY, Wilson SJ, Williams G, Harris MA, Cooper D. Age-related factors that confound peripheral pulse timing characteristics in Caucasian children. J Hum Hypertens. 2005 Jun;19(6):463-6. doi: 10.1038/sj.jhh.1001846.
Background: PubMed 1727960Dickersin K, Min YI, Meinert CL. Factors influencing publication of research results. Follow-up of applications submitted to two institutional review boards. JAMA. 1992 Jan 15;267(3):374-8.
Background: PubMed 15920454Foo JY, Wilson SJ, Williams G, Harris MA, Cooper D. Pulse transit time as a derived noninvasive mean to monitor arterial distensibility changes in children. J Hum Hypertens. 2005 Sep;19(9):723-9. doi: 10.1038/sj.jhh.1001891.
Background: PubMed 16720953Foo JY, Lim CS. Pulse transit time as an indirect marker for variations in cardiovascular related reactivity. Technol Health Care. 2006;14(2):97-108.
Background: PubMed 8462395Harris MI. Undiagnosed NIDDM: clinical and public health issues. Diabetes Care. 1993 Apr;16(4):642-52. doi: 10.2337/diacare.16.4.642. No abstract available.
Background: PubMed 19308667Jaryal AK, Selvaraj N, Santhosh J, Anand S, Deepak KK. Monitoring of cardiovascular reactivity to cold stress using digital volume pulse characteristics in health and diabetes. J Clin Monit Comput. 2009 Apr;23(2):123-30. doi: 10.1007/s10877-009-9174-z. Epub 2009 Mar 24.
Background: PubMed 2400747Kinsella SM, Whitwam JG, Spencer JA. Aortic compression by the uterus: identification with the Finapres digital arterial pressure instrument. Br J Obstet Gynaecol. 1990 Aug;97(8):700-5. doi: 10.1111/j.1471-0528.1990.tb16242.x.
Background: PubMed 11408390Kelly RP, Millasseau SC, Ritter JM, Chowienczyk PJ. Vasoactive drugs influence aortic augmentation index independently of pulse-wave velocity in healthy men. Hypertension. 2001 Jun;37(6):1429-33. doi: 10.1161/01.hyp.37.6.1429.

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Recruiting
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Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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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.

The record lists no contact. Use the official record to reach the sponsor.

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 II, run by Medical University of Vienna at 1 site in Austria.

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 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 7 Jan 2014. 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 Austria. 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?

Pulse wave arrival time difference between finger and toe, duration of diabetes (time frame: 1 Minute data recording of the pulse waves at four sites.). 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 NCT02028091, which also lists 12 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 7 Jan 2014.