The Predictive Value of Sidestream Dark Field Imaging in Diabetic Nephropathy

Third Military Medical University

Status: Completed

Conditions: Microcirculation Detection in Diabetic Patients

Treatments: Device: Sidestream dark field(SDF) imagining

Study type: Observational

Funder types: Other

Identifiers

NCT04403945

PVSDFI-DN

Details and patient eligibility

About

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.

Enrollment: 143 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

143 participants in 3 patient groups

Group 1

Description:

healthy volunteers with normal fasting blood glucose and HbA1c, without hypertension, kidney diseases, or taking drugs that affects microcirculation

Treatment:

Device: Sidestream dark field(SDF) imagining

Group 2

Description:

type 2 diabetic patients without microvascular complications like Diabetic nephropathy, diabetic retinopathy, diabetic foot or diabetic peripheral neuropathy

Treatment:

Device: Sidestream dark field(SDF) imagining

Group 3

Description:

type 2 diabetic patients with diabetic nephropathy diagnosed by clinic or pathology.

Treatment:

Device: Sidestream dark field(SDF) imagining