Population Research of Sublingual Microcirculation Data of Patients With Systemic Diseases

NCT02940275 | Completed

• 1 other identifier: 201609021RINB
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Perfused small vessel density of sublingual small vessels measured by Cytocam

  Once at enrollment

Secondary Outcomes (1)

• Total small vessel density of sublingual small vessels measured by Cytocam

  Once at enrollment

Study Arms (7)

Hypertension

Diabetes mellitus

Hypertension and diabetes mellitus

End stage kidney disease

Kidney transplant recipient

Coronary artery disease

Peripheral arterial occlusive disease

Eligibility Criteria

• Age: 20 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with systemic diseases

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 20, 2016
• Study Start: October 17, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: March 4, 2019

Record last verified: 2019-02

Locations

TW (1)