The Correlation Between the Retrobulbar Hemodynamics and Intrarenal Hemodynamics in T2DM Patients During the Early Period

Study Overview
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Brief Summary
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Objective: The main target of this study was to research the early changes of retrobulbar and intrarenal hemodynamics, then to research the correlation between them in type 2 diabetes (T2DM) patients without diabetic kidney disease (DKD) and diabetic retinopathy (DR). Method: 35 T2DM patients (diabetes group) without vascular complications and 30 healthy people (control group) were recruited to research the early changes of renal function, retrobulbar and intrarenal hemodynamics, and then to research the correlation between them. The primary endpoints were the intrarenal hemodynamic (bilateral kidney RI) in bilateral interlobular renal arteries were evaluated using Doppler Sonographic; the secondary endpoints were the retrobulbar hemodynamics RI in the bilateral central retinal artery (CRA), posterior ciliary artery (PCA), and arteria ophthalmica (OA) were evaluated using color doppler imaging (CDI); the tertiary endpoints were the biochemical endpoints: blood-fat (TC, HDL-C, LDL-C, and TG), FPG, 2hPG, HbA1c, and renal function parameters (BUN, Cr, and GFR); in addition, the albumin excrete rate (AER), urinary albumin/creatinine ratio (UACR) were measured.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: Color doppler imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients were diagnosed with T2DM according to the guidelines of the American Diabetes Association ; No smoking history, pulmonary disease, cold, nor pulmonary infection within a fortnight; Did not have hepatopathy, nephropathy, hyperuricemia, and gastrointestinal disease; and Likely to have good compliance and able to visit our hospital for periodic assessments. Exclusion Criteria: T1DM, gestation and lactation; Renal inadequacy,hypohepatia,and heart failure; Intensive care with insulin treatment; The patients combined with DR and hypertension (antihypertensive drugs were used); Patients with other eye conditions that could affect the blood flow, such as high degree myopia, maculopathy of any origin, glaucoma, and those with a history of laser treatment or intraocular surgery; The patients combinated with DKD; Patients with other renal conditions that could affect the blood flow, such as urolithiasis, urinary infection, and renal cyst (diameter > 3 cm); Cholesterol-lowering drugs can not control the blood-fat (TC > 250 mg/dl, HDL-C < 30 mg/dL, LDL-C > 170 mg/dl, TG > 200 mg/dl) adequately.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| diabetes group<br>34 T2DM patients without vascular complications as diabetes group | Device: Color doppler imaging<br> <br> |
| control group<br>32 healthy people were recruited as control group | Device: Color doppler imaging<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrarenal hemodynamic (bilateral kidney RI) in bilateral interlobular renal arteries were evaluated using Doppler Sonographic in 34 patients | RI(resistivity index) | 3 weeks | 
| Retrobulbar RI in the bilateral Retrobulbar artery were evaluated using color doppler imaging (CDI) in 34 patients | RI(resistivity index),Retrobulbar artery［central retinal artery (CRA), posterior ciliary artery (PCA), and arteria ophthalmica (OA)］ | 3 weeks | 
| The correlation between the bilateral retrobulbar RI and bilateral kidney RI in 34 patients | RI(resistivity index) | 3 weeks |