Population Research of Sublingual Microcirculation Data of Patients With Systemic Diseases

NCT ID: NCT02940275

Last Updated: 2019-03-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 156 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-17
• Study Completion Date: 2018-09-01

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).

Conditions

Hypertension; Diabetes Mellitus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Hypertension

No interventions assigned to this group

Diabetes mellitus

No interventions assigned to this group

Hypertension and diabetes mellitus

No interventions assigned to this group

End stage kidney disease

No interventions assigned to this group

Kidney transplant recipient

No interventions assigned to this group

Coronary artery disease

No interventions assigned to this group

Peripheral arterial occlusive disease

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

201609021RINB

Identifier Type: -

Identifier Source: org_study_id