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

NCT ID: NCT02805543

Last Updated: 2016-06-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-05-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

diabetes group

34 T2DM patients without vascular complications as diabetes group

Color doppler imaging

Intervention Type: DEVICE

control group

32 healthy people were recruited as control group

Color doppler imaging

Intervention Type: DEVICE

Interventions

Color doppler imaging

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 66 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fourth People's Hospital of Shenyang

OTHER

Sponsor Role: lead

Responsible Party

Jin-song Kuang

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

F11-262-9-25

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20160204

Identifier Type: -

Identifier Source: org_study_id