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

Diabetes Mellitus, Type 2 Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805543
• Other study ID #: 20160204
• Secondary ID: F11-262-9-25
• Status: Completed
• Phase: N/A
• First received: June 12, 2016
• Last updated: June 17, 2016
• Start date: February 2016
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: Fourth People's Hospital of Shenyang
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Liaoning Province
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 66 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Device:
• Color doppler imaging

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fourth People's Hospital of Shenyang

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intrarenal hemodynamic (bilateral kidney RI) in bilateral interlobular renal arteries were evaluated using Doppler Sonographic in 34 patients	RI(resistivity index)	3 weeks	No
Primary	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	No
Primary	The correlation between the bilateral retrobulbar RI and bilateral kidney RI in 34 patients	RI(resistivity index)	3 weeks	No