Population Research of Sublingual Microcirculation Data of Patients With Systemic Diseases

Completed

• Conditions: Hypertension; Diabetes Mellitus

• Registration Number: NCT02940275
• Lead Sponsor: National Taiwan University Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-17
• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-10-18
• Study First Posted: 2016-10-20
• Primary Completion: 2018-09-01
• Study Completion: 2018-09-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-28
• Last Update Posted: 2019-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perfused small vessel density of sublingual small vessels measured by Cytocam	Once at enrollment

Secondary Outcome Measures

Name	Time	Method
Total small vessel density of sublingual small vessels measured by Cytocam	Once at enrollment

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan