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

NCT02028091 | Completed

• 1 other identifier: 1242/2012
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus Type II

Keywords

Pulse walve arrival time differences

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Patients over 18 years

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Related 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. doi: 10.1002/(SICI)1096-9136(199807)15:73.0.CO;2-S.

  PMID: 9686693 BACKGROUND

• 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.

  PMID: 11217886 BACKGROUND

• 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.

  PMID: 17233362 BACKGROUND

• 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.

  PMID: 10588217 BACKGROUND

• 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.

  PMID: 15729376 BACKGROUND

• 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.

  PMID: 1727960 BACKGROUND

• 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.

  PMID: 15920454 BACKGROUND

• 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.

  PMID: 16720953 BACKGROUND

• 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.

  PMID: 8462395 BACKGROUND

• 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.

  PMID: 19308667 BACKGROUND

• 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.

  PMID: 2400747 BACKGROUND

• 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.

  PMID: 11408390 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ao Univ. Prof. Dr.

Study Record Dates

• First Submitted: January 3, 2014
• First Posted: January 6, 2014
• Study Start: September 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 7, 2014

Record last verified: 2014-01

Locations

AU (1)