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NCT Number: NCT02940275

Population Research of Sublingual Microcirculation Data of Patients With Systemic Diseases

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).

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Key information

Age range

20 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Perfused small vessel density of sublingual small vessels measured by Cytocam

    Time frame: Once at enrollment

Secondary outcomes

  1. Total small vessel density of sublingual small vessels measured by Cytocam

    Time frame: Once at enrollment

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 20, 2016
Registry last updated
Mar 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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