HypertensionNCT02940275
Population Research of Sublingual Microcirculation Data of Patients With Systemic Diseases
An observational study of Hypertension and Diabetes Mellitus, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 89 years
- Conditions the study is for
- Hypertension, Diabetes Mellitus
- How many people
- 156 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Oct 2016to 1 Sep 2018
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with systemic diseases
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 11Show fewer
- Hematological disorders
- Uncured cancer
- Chronic uncured infection
- Other major disease with limited daily activity
- Non-native speakers
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Hypertension, Diabetes Mellitus
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 |
|---|---|---|
| Hypertension | Not described | |
| Diabetes mellitus | Not described | |
| Hypertension and diabetes mellitus | Not described | |
| End stage kidney disease | Not described | |
| Kidney transplant recipient | Not described | |
| Coronary artery disease | Not described | |
| Peripheral arterial occlusive disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfused small vessel density of sublingual small vessels measured by Cytocam
Measured: Once at enrollment
Secondary outcomes (1)
Total small vessel density of sublingual small vessels 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 posted20 Oct 2016 (estimated)
- Study start17 Oct 2016
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940275
- Sponsor's protocol ID
- 201609021RINB
- Status last verified
- Feb 2019
- First submitted
- 18 Oct 2016
- 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 Patients With Systemic Diseases
- ClinicalTrials.gov ID
- NCT02940275
- Acronym / sponsor ID
- 201609021RINB
- Conditions
- Hypertension, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 17 Oct 2016
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 20 Oct 2016 (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 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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Hypertension | – | – |
| Diabetes mellitus | – | – |
| Hypertension and diabetes mellitus | – | – |
| End stage kidney disease | – | – |
| Kidney transplant recipient | – | – |
| Coronary artery disease | – | – |
| Peripheral arterial occlusive disease | – | – |
Who may qualify
- Ages
- 20 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with systemic diseases
Key inclusion criteria (10 listed)
- Patients aged from 20 to 79 years old
- BMI ranged from 18.5 to 27 kg/m2
- Presence of one of the condition
Key exclusion criteria (11 listed)
- 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
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
Perfused small vessel density of sublingual small vessels measured by Cytocam
Time frame: Once at enrollment
1 secondary outcome
Total 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypertension and Diabetes Mellitus, 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 10 inclusion and 11 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?
Perfused 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 7 Nov 2026.