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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Device: Color doppler imaging

• Registration Number: NCT02805543
• Lead Sponsor: Fourth People's Hospital of Shenyang

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-06
• Study First Submitted: 2016-06-12
• Study First Submitted QC: 2016-06-17
• Last Update Submitted: 2016-06-17
• Study First Posted: 2016-06-20
• Last Update Posted: 2016-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1. The patients were diagnosed with T2DM according to the guidelines of the American Diabetes Association ;
2. No smoking history, pulmonary disease, cold, nor pulmonary infection within a fortnight;
3. Did not have hepatopathy, nephropathy, hyperuricemia, and gastrointestinal disease; and
4. Likely to have good compliance and able to visit our hospital for periodic assessments.

Exclusion Criteria

1. T1DM, gestation and lactation;
2. Renal inadequacy,hypohepatia,and heart failure;
3. Intensive care with insulin treatment;
4. The patients combined with DR and hypertension (antihypertensive drugs were used);
5. 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;
6. The patients combinated with DKD;
7. Patients with other renal conditions that could affect the blood flow, such as urolithiasis, urinary infection, and renal cyst (diameter > 3 cm);
8. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	Color doppler imaging	32 healthy people were recruited as control group
diabetes group	Color doppler imaging	34 T2DM patients without vascular complications as diabetes group

Primary Outcome Measures

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