NCT02412839

Brief Summary

This study will enroll 150 healthy volunteers, and the grouping is as follows: group 20-39 (30 males and 30 females); group 40-59 (30 males and 30 females); and group 60-79 (15 males and 15 females). The sublingual microcirculation will be examined with the incident dark field video microscope (Cytocam，Braedius Battery Powered Transilluminator). The study aims to compare the differences of microcirculation among the three groups and between genders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2017

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
Last Updated

March 4, 2019

Status Verified

February 1, 2019

Enrollment Period

1.9 years

First QC Date

April 6, 2015

Last Update Submit

February 28, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

    Total small vessel density will be measured by Cytocam

    Once at enrollment

Secondary Outcomes (1)

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

    Once at enrollment

Study Arms (3)

Group 20-39

Patients aged from 20 to 39 years old. 30 males and 30 females.

Group 40-59

Patients aged from 40 to 59 years old. 30 males and 30 females.

Group 60-79

Patients aged from 60 to 79 years old. 15 males and 15 females.

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy Volunteers

You may qualify if:

  • Healthy volunteers aged from 20 to 79 years old
  • BMI ranged from 18.5 to 27 kg/m2

You may not qualify if:

  • Systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 95 mm Hg, or systolic blood pressure \< 90 mm Hg at enrollment
  • Body temperature \> 37.5 ℃ or \< 35.5 ℃ at enrollment
  • had been diagnose with any one of the following diseases
  • hypertension
  • diabetes mellitus
  • peripheral arterial occlusive disease
  • coronary arterial disease
  • liver cirrhosis
  • chronic kidney disease
  • stroke
  • anemia
  • asthma
  • chronic bronchitis
  • any metabolic diseases
  • any hematologic disease
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Study Officials

  • Yu-Chang Yeh, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2015

First Posted

April 9, 2015

Study Start

April 1, 2015

Primary Completion

February 15, 2017

Study Completion

February 28, 2017

Last Updated

March 4, 2019

Record last verified: 2019-02

Locations

TW(1)