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

NCT ID: NCT02028091

Last Updated: 2014-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus Type II

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diabetes mellitus

All patients over 18 years with diagnosed diabetes mellitus type II.

No interventions assigned to this group

Non Diabetic

Patients over 18 years with no known diabetes mellitus or other known/diagnosed vascular diseases.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients over 18 years

Exclusion Criteria

* Diabetic foot gangrene
* No possibility of pulse wave velocitiy measurement on the finger or toe
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wolfgang SCHRAMM

Ao Univ. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University of Vienna

Vienna, Vienna, Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 9686693 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11217886 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17233362 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10588217 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15729376 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1727960 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15920454 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16720953 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8462395 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19308667 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2400747 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11408390 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1242/2012

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Patients With Type 2 Diabetes
NCT07245082 RECRUITING