Diabetic Nephropathy
Conditions
Brief summary
The purpose of this study is to evaluate the effect of lipo-prostaglandin E1 （lipo-PGE1) on renal oxygenation in patients with diabetic nephropathy by blood oxygenation level dependent magnetic resonance imaging (BOLD-MRI).patients with stable chronic kidney disease (CKD) were included. All patients were divided into two groups: diabetic nephropathy（DN) and CKD without diabetes. In addition to the conventional treatments, all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days. Kidney BOLD-MRI were performed before and after lipo-PGE1 administration to acquire bilateral renal cortical R2\*(CR2\*) and medullary R2\* (MR2\*) values. Meanwhile, the clinical indexes at baseline and under lipo-PGE1 including 24 hours urinary protein and serum creatinine were collected. the investigators want to prove Lipo-PGE1 can improve kidney medullary oxygenation in patients with DN.
Detailed description
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.
Interventions
DRUGLipo-PGE1
all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days
Sponsors
West China Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of chronic kidney disease
Exclusion criteria
* Intolerance to lipo-PGE1, contraindication for MRI, concurrent urinary tract infection, acute kidney injury, acute cardiovascular and cerebrovascular complications and diabetic emergencies, with the use of corticosteroid and diureses.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Change of Tissue Content of Deoxyhemoglobin Assessed by BOLD-MRI | 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 |
Countries
China
Participant flow
Recruitment details
Our overall recruiting cycle for 40 days, mainly for patients with chronic kidney disease patients, which is divided into diabetic nephropathy and non-diabetic patients
Pre-assignment details
Chronic kidney disease patients were divided into diabetic nephropathy and non-diabetic group, ordinary chronic kidney disease patients with diabetes mellitus were excluded
Participants by arm
| Arm | Count |
|---|---|
| Lipo-prostaglandin E1 all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days.
Lipo-PGE1: all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Lipo-prostaglandin E1 |
|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 13 |
| Gender Female | 12 Participants |
| Gender Male | 9 Participants |
| R2* values | 23.32 1/ms STANDARD_DEVIATION 6.48 |
| Region of Enrollment China | 21 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
the Change of Tissue Content of Deoxyhemoglobin Assessed by BOLD-MRI
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
Time frame: baseline and after 14days of lipo-PGE1 intravenously
Population: A random sample, west China hospital, in accord with a standard 21 people,age \> 18 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetic Nephropathy,Chronic Kidney Disease | the Change of Tissue Content of Deoxyhemoglobin Assessed by BOLD-MRI | 22.04 1/ms | Standard Deviation 6.15 |