Population Research of Sublingual Microcirculation Data of Patients With Systemic Diseases

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02940275

Enrollment

156

Registered

2016-10-20

Start date

2016-10-17

Completion date

2018-09-01

Last updated

2019-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Hypertension

Brief summary

This is an observational clinical study, patients with systemic diseases will be enrolled according to the inclusion and exclusion criteria. Patients will received the examination of sublingual microcirculation by using incident dark field video microscope (Cytocam，Braedius Battery Powered Transilluminator). The microcirculation data includes total small vessel density, perfused small vessel density, microvascular flow index, and heterogeneity index. The patients will be divided into right groups according to their systemic diseases as follows: group 1 hypertension (60 patients), group 2 diabetes mellitus (60), group 3 hypertension and diabetes mellitus (60), group 4 end stage renal disease with hemodialysis (60), group 5 kidney transplant recipients (60), group 6 coronary artery disease (60), and group 7 peripheral arterial occlusive disease (60).

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

20 Years to 89 Years

Healthy volunteers

Inclusion criteria

* Patients aged from 20 to 79 years old * BMI ranged from 18.5 to 27 kg/m2 * Presence of one of the condition * Diagnosed hypertension \> 6 months, without other systemic diseases * Diagnosed diabetes mellitus \> 6 months, without other systemic diseases * Diagnosed with both hypertension and diabetes mellitus \> 6 months, without other systemic diseases * Diagnosed with end stage renal disease \> 6 months * Received renal replacement therapy \> 6 months * Diagnosed with coronary artery disease \> 6 months * Diagnosed with peripheral arterial occlusive diseases \> 6 months

Exclusion criteria

* Diagnosed with sepsis, major trauma, or admission to ICU within one month * Body temperature higher than 37.5 ℃ or lower than 35.5 ℃ * Any on of the following condition * Asthma * Chronic obstructive pulmonary disease * Endocrine diseases * Hematological disorders * Uncured cancer * Chronic uncured infection * Other major disease with limited daily activity * Non-native speakers

Design outcomes

Primary

Measure	Time frame
Perfused small vessel density of sublingual small vessels measured by Cytocam	Once at enrollment

Secondary

Measure	Time frame
Total small vessel density of sublingual small vessels measured by Cytocam	Once at enrollment

Countries

Taiwan

Outcome results