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.
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Notify MeKey information
Conditions
Age range
35 year–66 year
Sex eligibility
All sexes
Study type
Observational
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
Primary outcomes
-
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)
-
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)]
-
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.
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