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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Device: Color doppler imaging

• Study Type: Observational
• Enrollment (Actual): 66

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The investigators selected 45 T2DM patients (25 males, 20 females) without microangiopathy (DR and DKD) as diabetes group and 38 healthy people (21 males, 17 females) as control group from the diabetic outpatient clinic in Shenyang the Fourth Hospital of People, but only 34 patients (19 males, 15 females) in the diabetes group and 32 healthy people (17 males, 15 females) can be researched in our study, all the participants were the Chinese Hans. All patients were provided a diet and exercise program by professional nutritionists.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
diabetes group; 34 T2DM patients without vascular complications as diabetes group	Device: Color doppler imaging
control group; 32 healthy people were recruited as control group	Device: Color doppler imaging

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fourth People's Hospital of Shenyang

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: June 12, 2016
• First Submitted That Met QC Criteria: June 17, 2016
• First Posted (Estimate): June 20, 2016

Study Record Updates

• Last Update Posted (Estimate): June 20, 2016
• Last Update Submitted That Met QC Criteria: June 17, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 20160204; F11-262-9-25 (Natural Science Foundation of Shenyang)