Skip to main content
OpenTrials
Completed

NCT Number: NCT02805543

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Color Doppler Imaging

Device

Primary outcomes

  1. Intrarenal hemodynamic (bilateral kidney RI) in bilateral interlobular renal arteries were evaluated using Doppler Sonographic in 34 patients

    Time frame: 3 weeks

    RI(resistivity index)

  2. Retrobulbar RI in the bilateral Retrobulbar artery were evaluated using color doppler imaging (CDI) in 34 patients

    Time frame: 3 weeks

    RI(resistivity index),Retrobulbar artery[central retinal artery (CRA), posterior ciliary artery (PCA), and arteria ophthalmica (OA)]

  3. The correlation between the bilateral retrobulbar RI and bilateral kidney RI in 34 patients

    Time frame: 3 weeks

    RI(resistivity index)

Sponsors and collaborators

Lead sponsor

Fourth People's Hospital of Shenyang

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 20, 2016
Registry last updated
Jun 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.