Microcirculation Detection in Diabetic PatientsNCT04403945
The Predictive Value of Sidestream Dark Field Imaging in Diabetic Nephropathy
An observational study of Microcirculation Detection in Diabetic Patients, run by Third Military Medical University at 1 site in China.
Trial summary
Diabetic microangiopathy refers to the pathological changes of arterioles, capillaries and venules in diabetic patients. Due to the impacts including glycol-metabolism disorder, disturbance of lipid metabolism, cytokine, oxidative stress and hemodynamic changes, the structure and function of microvessels are damaged… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Microcirculation Detection in Diabetic Patients
- What is being tested?
- Sidestream dark field(SDF) imagining
- Type of treatment
- Medical device
- How many people
- 143 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 1 Mar 2021
- How long will I take part?
- 21 Months
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We collected clinical data of 100 cases with T2DM who hospitalized in our treatment center from March 2019 to September 2020, and SDFI was taken properly.
Who may be able to join
- age ranges from 18 to 70 years old
- signed informed consent
Who cannot join
- Younger than 18 years old or older than 70 years old
- Shock patients who have low blood pressure under 90/60mmHg
- Patients with mental abnormality who are uncooperative with this study
- Having difficulty in mouth opening
- Patients with Ketoacidosis
- Oral mucosal inflammation or injury, which could locally influence the sublingual microvasculature
- Pregnant or lactating women
- Refuse to sign informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
The third hospital affiliated to the Third Military Medical University
Chongqing, Chongqing Municipality, 400042
About this study
Official title: The Predictive Value of Sidestream Dark Field Imaging in Diabetic Nephropathy: a Observational Clinical Trial Evaluating the Predictive Value of SDF in DN
Diabetic microangiopathy refers to the pathological changes of arterioles, capillaries and venules in diabetic patients. Due to the impacts including glycol-metabolism disorder, disturbance of lipid metabolism, cytokine, oxidative stress and hemodynamic changes, the structure and function of microvessels are damaged accordingly. Diabetic nephropathy (DN) is one of the most common and serious chronic microvascular complications of diabetes, and becomes a leading cause of end-stage renal failure(ESRF). Presently, urinary albumin/creatinine ratio (UACR) is a widely accepted and relatively reliable indicator for early diagnosis of DN, however, there are 2/3 DN patients with normal albuminuria have decreased glomerular filtration rate (glomerular filtration rate, GFR) and abnormal structure of the kidney, one the other hand, the presence of albuminuria is associated with other vascular dysfunction and kidney disease other than DN, therefore its accuracy is increasingly being challenged.
Sidestream dark field(SDF) imagining technology, as an emerging way to visualize blood vessels, is evaluated in a semi-quantitative manner and provides an effective means to study structure and function of microcirculation. Different from biochemical markers like albuminuria, SDF provides a visual information about vessel structure, density, and quality of diffusion. At present the research of sublingual microcirculation by SDF technique is mainly applied to microcirculation monitoring in patients in the intensive care unit or laboratory animal models with acute hemorrhagic shock to assess the potential of being a tool of diagnosis and treatment prognostic indicator, no relevant research has been carried out to evaluate the predictive value of diabetic microangiopathy in literature so far.
Herein, the investigators designed the study based on SDF imaging to collect scientific data, thus providing strong support for the early assessment and diagnosis of diabetic nephropathy and possibly guiding individual therapy in the future.
- Being tested
- Sidestream dark field(SDF) imagining
- Keywords
- Type 2 Diabetes Mellitus; Sidestream dark field imaging; sublingual microcirculation
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sidestream dark field(SDF) imaginingDevice
SDF imaging consists of a hand-held device that illuminates a region by surrounding a central light guide with concentrically placed light emitting diodes,which thus provide SDF illumination.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | healthy volunteers with normal fasting blood glucose and HbA1c, without hypertension, kidney diseases, or taking drugs that affects microcirculation Receives: Device: Sidestream dark field(SDF) imagining | |
| Group 2 | type 2 diabetic patients without microvascular complications like Diabetic nephropathy, diabetic retinopathy, diabetic foot or diabetic peripheral neuropathy Receives: Device: Sidestream dark field(SDF) imagining | |
| Group 3 | type 2 diabetic patients with diabetic nephropathy diagnosed by clinic or pathology. Receives: Device: Sidestream dark field(SDF) imagining |
What is being measured
The primary outcome is the main question the study is designed to answer.
the comparison of the density of total length of the small perfusd vessels(PDV) in the acquisition window between the 3 groups
We use dark-field microcirculation microscopic observation System (Chinese Advanced Vessel Analyse Contrast System 4.0, C - AVA - C version 4.0) developed by Li Hua company to compare interesting parameters of vessels between the three groups. PVD is one of the parameters indicated of the perfused vessel density, calculated by the ratio of the length of small perfusion vessels to the visual field area (unit: mm/mm2)
Measured: 21 months
Secondary outcomes (3)
the comparison of The density of the total length of small vessels(TVD) in the area of the acquisition window between the 3 groups
We use dark-field microcirculation microscopic observation System (Chinese Advanced Vessel Analyse Contrast System 4.0, C - AVA - C version 4.0) developed by Li Hua company to compare interesting parameters of vessels between the three groups. TVD is one of the parameters indicated of the total vessel density, calculated by the ratio of the length of all small vessels to the visual field area (unit: mm/mm2)
Measured: 21 months
the comparison of Proportion of De Backer density score between the 3 groups
The score is the result of counting the number of intersections of capillaries with predetermined grid lines and measurement of total capillary length relative to image surface are similarly reliable measures of functional capillary density
Measured: 21 months
Correlation comparison: The correlation between SDF vascular parameters and the clinical data of the subjects was compared
Main clinical data:1. microalbuminuria；2.microalbuminuria creatinine ratio；3.Ankle brachial index；4.toe brachial index
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Jun 2019
- Primary completion1 Jan 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microcirculation Detection in Diabetic PatientsStudies of the same condition, open and under way.
- 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
- 143 participants (actual)
- Target duration
- 21 Months
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiming Zhu, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403945
- Sponsor's protocol ID
- PVSDFI-DN
- Status last verified
- Jul 2021
- First submitted
- 21 May 2020
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Sidestream Dark Field Imaging in Diabetic Nephropathy: a Observational Clinical Trial Evaluating the Predictive Value of SDF in DN
- ClinicalTrials.gov ID
- NCT04403945
- Acronym / sponsor ID
- PVSDFI-DN
- Keywords
- Type 2 Diabetes Mellitus; Sidestream dark field imaging; sublingual microcirculation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 27 May 2020 (actual)
- 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.
Diabetic microangiopathy refers to the pathological changes of arterioles, capillaries and venules in diabetic patients. Due to the impacts including glycol-metabolism disorder, disturbance of lipid metabolism, cytokine, oxidative stress and hemodynamic changes, the structure and function of microvessels are damaged accordingly. Diabetic nephropathy (DN) is one of the most common and serious chronic microvascular complications of diabetes, and becomes a leading cause of end-stage renal failure(ESRF). Presently, urinary albumin/creatinine ratio (UACR) is a widely accepted and relatively reliable indicator for early diagnosis of DN, however, there are 2/3 DN patients with normal albuminuria have decreased glomerular filtration rate (glomerular filtration rate, GFR) and abnormal structure of the kidney, one the other hand, the presence of albuminuria is associated with other vascular dysfunction and kidney disease other than DN, therefore its accuracy is increasingly being challenged.
Sidestream dark field(SDF) imagining technology, as an emerging way to visualize blood vessels, is evaluated in a semi-quantitative manner and provides an effective means to study structure and function of microcirculation. Different from biochemical markers like albuminuria, SDF provides a visual information about vessel structure, density, and quality of diffusion. At present the research of sublingual microcirculation by SDF technique is mainly applied to microcirculation monitoring in patients in the intensive care unit or laboratory animal models with acute hemorrhagic shock to assess the potential of being a tool of diagnosis and treatment prognostic indicator, no relevant research has been carried out to evaluate the predictive value of diabetic microangiopathy in literature so far.
Herein, the investigators designed the study based on SDF imaging to collect scientific data, thus providing strong support for the early assessment and diagnosis of diabetic nephropathy and possibly guiding individual therapy in the future.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 21 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: Sidestream dark field(SDF) imagininghealthy volunteers with normal fasting blood glucose and HbA1c, without hypertension, kidney diseases, or taking drugs that affects microcirculation |
| Group 2 | – | Device: Sidestream dark field(SDF) imaginingtype 2 diabetic patients without microvascular complications like Diabetic nephropathy, diabetic retinopathy, diabetic foot or diabetic peripheral neuropathy |
| Group 3 | – | Device: Sidestream dark field(SDF) imaginingtype 2 diabetic patients with diabetic nephropathy diagnosed by clinic or pathology. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We collected clinical data of 100 cases with T2DM who hospitalized in our treatment center from March 2019 to September 2020, and SDFI was taken properly.
Key inclusion criteria (2 listed)
- age ranges from 18 to 70 years old
- signed informed consent
Key exclusion criteria (8 listed)
- Younger than 18 years old or older than 70 years old
- Shock patients who have low blood pressure under 90/60mmHg
- Patients with mental abnormality who are uncooperative with this study
- Having difficulty in mouth opening
- Patients with Ketoacidosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sidestream dark field(SDF) imaginingSDF imaging consists of a hand-held device that illuminates a region by surrounding a central light guide with concentrically placed light emitting diodes,which thus provide SDF illumination. | Device | Group 1, Group 2, Group 3 |
Primary outcome
the comparison of the density of total length of the small perfusd vessels(PDV) in the acquisition window between the 3 groups
Time frame: 21 months
We use dark-field microcirculation microscopic observation System (Chinese Advanced Vessel Analyse Contrast System 4.0, C - AVA - C version 4.0) developed by Li Hua company to compare interesting parameters of vessels between the three groups. PVD is one of the parameters indicated of the perfused vessel density, calculated by the ratio of the length of small perfusion vessels to the visual field area (unit: mm/mm2)
3 secondary outcomes
the comparison of The density of the total length of small vessels(TVD) in the area of the acquisition window between the 3 groups
Time frame: 21 months
the comparison of Proportion of De Backer density score between the 3 groups
Time frame: 21 months
Correlation comparison: The correlation between SDF vascular parameters and the clinical data of the subjects was compared
Time frame: 21 months
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 27 Jul 2021.
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 Microcirculation Detection in Diabetic Patients, run by Third Military Medical University at 1 site in China.
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 8 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 27 Jul 2021. 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 China. 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?
the comparison of the density of total length of the small perfusd vessels(PDV) in the acquisition window between the 3 groups (time frame: 21 months). 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 27 Jul 2021.