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

Diabetes Mellitus Type II Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02028091
• Other study ID #: 1242/2012
• Status: Completed
• Phase: N/A
• First received: January 3, 2014
• Last updated: January 4, 2014
• Start date: September 2012
• Est. completion date: January 2013

Study information

• Verified date: January 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over 18 years

Exclusion Criteria:

• Diabetic foot gangrene

• No possibility of pulse wave velocitiy measurement on the finger or toe

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type II
• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

Chowienczyk PJ, Kelly RP, MacCallum H, Millasseau SC, Andersson TL, Gosling RG, Ritter JM, Anggård 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Harris MI. Undiagnosed NIDDM: clinical and public health issues. Diabetes Care. 1993 Apr;16(4):642-52. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 Minute data recording of the pulse waves at four sites.	No