Population Research of Sublingual Microcirculation Data of Patients With Systemic Diseases

Hypertension Clinical Trial

Official title:

Population Research of Sublingual Microcirculation Data of Patients With Systemic Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02940275
• Other study ID #: 201609021RINB
• Status: Completed
• Start date: October 17, 2016
• Est. completion date: September 1, 2018

Study information

• Verified date: February 2019
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hypertension

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perfused small vessel density of sublingual small vessels measured by Cytocam		Once at enrollment
Secondary	Total small vessel density of sublingual small vessels measured by Cytocam		Once at enrollment