The Predictive Value of Sidestream Dark Field Imaging in Diabetic Nephropathy
NCT ID: NCT04403945
Last Updated: 2021-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
143 participants
OBSERVATIONAL
2019-06-01
2021-03-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Group 1
healthy volunteers with normal fasting blood glucose and HbA1c, without hypertension, kidney diseases, or taking drugs that affects microcirculation
Sidestream dark field(SDF) imagining
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.
Group 2
type 2 diabetic patients without microvascular complications like Diabetic nephropathy, diabetic retinopathy, diabetic foot or diabetic peripheral neuropathy
Sidestream dark field(SDF) imagining
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.
Group 3
type 2 diabetic patients with diabetic nephropathy diagnosed by clinic or pathology.
Sidestream dark field(SDF) imagining
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.
Interventions
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Sidestream dark field(SDF) imagining
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.
Eligibility Criteria
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Inclusion Criteria
* signed informed consent
Exclusion Criteria
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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Third Military Medical University
OTHER
Responsible Party
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Zhiming Zhu
Director of the department of Hypertension & Endocrinology, Daping Hospital
Locations
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The third hospital affiliated to the Third Military Medical University
Chongqing, Chongqing Municipality, China
Countries
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Other Identifiers
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PVSDFI-DN
Identifier Type: -
Identifier Source: org_study_id
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