Lipo-prostaglandin E1 Improves Renal Hypoxia Evaluated by BOLD-MRI in Patients With Diabetic Nephropathy
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|ClinicalTrials.gov Identifier: NCT02628106|
Recruitment Status : Completed
First Posted : December 11, 2015
Results First Posted : May 24, 2016
Last Update Posted : December 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Nephropathy||Drug: Lipo-PGE1||Phase 4|
R2* maps were calculated using the in-house software in Matlab (version 7.0, The MathWorks, Inc., Cambridge, MA, USA) on a pixel-by-pixel basis by fitting㏑(signal intensity) versus echo time. The R2* map was windowed from 0 to 60 s-1.
Regions of interest (ROIs) with unfixed size (7 to 53 pixels) were defined at the upper, middle and lower poles of both kidneys in the medulla and cortex in the renal hilum plane based on the anatomical images. Three ROIs were placed in the medulla and cortex, respectively, carefully avoiding vessels, renal sinus and susceptibility artifacts, yielding a total of 6 ROIs in both kidneys. The values in each ROI were averaged for the bilateral cortex and medulla. To prevent significant bias from measurement variability, each sample was measured independently by three professional radiologists with more than 5 years of experience who were blinded to the clinical results. Thereafter, assuming the tests were coincident, the results were the averaged.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lipo-prostaglandin E1 Improves Renal Hypoxia Evaluated by BOLD-MRI in Patients|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||February 2016|
Experimental: Lipo-prostaglandin E1
all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days.
all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days
Other Name: alprostadil
- the Change of Tissue Content of Deoxyhemoglobin Assessed by BOLD-MRI [ Time Frame: baseline and after 14days of lipo-PGE1 intravenously ]the R2* value at the time after 14days of lipo-PGE1 intravenously minus the value at the baseline，R2* is a measure of the tissue content of deoxyhemoglobin. Which is inversely proportional to oxygen content in tissue
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02628106
|Chengdu, Sichuan, China, 641000|
|Study Chair:||fang liu, doctor||Department of Nephrology, West China Hospital of Sichuan University|