Clinical trial NCT04403945: The Predictive Value of Sidestream Dark Field Imaging in Diabetic Nephropathy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microcirculation Detection in Diabetic Patients
Keywords: Type 2 Diabetes Mellitus; Sidestream dark field imaging; sublingual microcirculation
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* age ranges from 18 to 70 years old
* signed informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: the comparison of the density of total length of the small perfusd vessels(PDV) in the acquisition window between the 3 groups
timeFrame: 21 months
Secondary outcomes:
measure: the comparison of The density of the total length of small vessels(TVD) in the area of the acquisition window between the 3 groups
timeFrame: 21 months
measure: the comparison of Proportion of De Backer density score between the 3 groups
timeFrame: 21 months
measure: Correlation comparison: The correlation between SDF vascular parameters and the clinical data of the subjects was compared
timeFrame: 21 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The third hospital affiliated to the Third Military Medical University
state: Chongqing
Study officials:
References: