HealthyNCT02412839
Sublingual Microcirculation of Healthy Volunteers by Using the Third Generation Microcirculation Video Microscope
An observational study of Healthy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2015to 28 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Volunteers
Who may be able to join
- Healthy volunteers aged from 20 to 79 years old
- BMI ranged from 18.5 to 27 kg/m2
Who cannot join
- 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
Show all 19Show fewer
- coronary arterial disease
- liver cirrhosis
- chronic kidney disease
- stroke
- anemia
- asthma
- chronic bronchitis
- any metabolic diseases
- any hematologic disease
- uncured cancer
- chronic uncontrolled infection
- other disease may limit daily activities
- non-native speakers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Population Research of Sublingual Microcirculation Data of Healthy Volunteers by Using the Third Generation Microcirculation Video Microscope
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.
- Conditions
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total small vessel density of sublingual small vessels measured by Cytocam
Total small vessel density will be measured by Cytocam
Measured: Once at enrollment
Secondary outcomes (1)
Perfused small vessel density of sublingual small vessels measured by Cytocam
Perfused small vessel density will be measured by Cytocam
Measured: Once at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startApr 2015
- Primary completion15 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Chang Yeh, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412839
- Sponsor's protocol ID
- 201502027RIND
- Status last verified
- Feb 2019
- First submitted
- 6 Apr 2015
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Research of Sublingual Microcirculation Data of Healthy Volunteers by Using the Third Generation Microcirculation Video Microscope
- ClinicalTrials.gov ID
- NCT02412839
- Acronym / sponsor ID
- 201502027RIND
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 9 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Volunteers
Key inclusion criteria (2 listed)
- Healthy volunteers aged from 20 to 79 years old
- BMI ranged from 18.5 to 27 kg/m2
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total small vessel density of sublingual small vessels measured by Cytocam
Time frame: Once at enrollment
Total small vessel density will be measured by Cytocam
1 secondary outcome
Perfused small vessel density of sublingual small vessels measured by Cytocam
Time frame: Once at enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
Related trials for Healthy
RecruitingObservational study
Studies of Blood Flow to the Brain During Thought
Healthy Volunteer
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
Enrolling by invitationObservational study
Collection and Distribution of Samples From Healthy Donors for In Vitro Research at the NCI-Frederick
Healthy Donors
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Chang Yeh, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total small vessel density of sublingual small vessels measured by Cytocam (time frame: Once at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2019; AzTrials last refreshed its copy on 6 Nov 2026.