Clinical trial NCT02028091: Diabetes Mellitus - A Diagnosis Trial by Means of Non Invasive Measurements
Official title: Diabetes Mellitus - A Diagnosis Trial by Means of Non Invasive Measurements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus Type II
Keywords: Pulse walve arrival time differences
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2014-01-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years

Exclusion Criteria:

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

Primary outcomes:
measure: Pulse wave arrival time difference between finger and toe, duration of diabetes
timeFrame: 1 Minute data recording of the pulse waves at four sites.
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
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