UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034609 |
|---|---|
| Receipt number | R000039456 |
| Scientific Title | Assessment of early diabetic nephropathy using Functional MR imaging |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2024/04/30 13:14:28 |
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Basic information
Public title
Assessment of early diabetic nephropathy using Functional MR imaging
Acronym
Functional imaging of early diabetic nephropathy
Scientific Title
Assessment of early diabetic nephropathy using Functional MR imaging
Scientific Title:Acronym
Functional imaging of early diabetic nephropathy
Region
| Japan |
Condition
Condition
Diabetic nephropathy
Classification by specialty
| Endocrinology and Metabolism | Nephrology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the renal function of early stage diabetic nephropathy using functional MR imaging
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Usefulness of MR imaging to evaluate early stage diabetic nephropathy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
diabetic nephropathy Staying still for 30 minutes to perform MR imaging
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients of diabetic nephropathy or Healthy volunteer
Key exclusion criteria
The patients who have renal disease other than diabetic nephropathy
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Yamamoto |
Organization
Kawasaki Medical School
Division name
Radiology
Zip code
7010192
Address
577 Matsushima Kurashiki Okayama Japan
TEL
086-462-1111
jiro@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Yamamoto |
Organization
Kawasaki Medical School
Division name
Radiology
Zip code
7010192
Address
577 Matsushima Kurashiki Okayama Japan
TEL
086-462-1111
Homepage URL
jiro@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Depertment of Radiology Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kawasaki Medical School
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee of Kawasaki Medical School and Hospital
Address
577 Matsushima Kurashiki Okayama Japan
Tel
086-462-1111
kmsrec@med.kawasaki-m.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000039456
Publication of results
Partially published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000039456
Number of participants that the trial has enrolled
122
Results
Significant differences were observed in T1 value between low risk group (0.78)vs.moderate risk group (0.82) (P<0.001) and moderate risk group (0.82)vs.high risk group (0.88) (P=0.001),in T2 value between healthy group (0.97)vs.low risk group (1.01), and in SSFP with IR pulse on optimal TI between healthy group (4.66)vs.low risk group (5.32) (P=0.016),low risk group (5.32)vs.moderate risk group (4.11) (P=0.004), very high risk group (2.79)vs.highest risk group (2.22) (P=0.011).
Results date posted
| 2024 | Year | 04 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 122 cases, including 23 healthy volunteers and 99 diabetic patients, were studied.
Participant flow
A total of 122 cases, including 23 healthy volunteers and 99 diabetic patients, were studied. Diabetic patients were classified into 5 groups; low risk group (n=27), moderate risk group (n=19), high risk group (n=12), very high risk group (n=22), and highest risk group (n=19) based on the KDIGO 2022
Adverse events
none
Outcome measures
All subjects underwent non-contrast MRI using a 3-Tesla MRI machine. Measurements were made of the renal cortex and renal medulla T1 values, T2 values, blood oxygenation level dependent (BOLD) imaging (T2* values and R2* values), intravoxel incoherent motion (IVIM) imaging (ADC, f, D* and D values), arterial spin labeling (ASL) as well as optimal inversion time (TI) (= TI of maximum corticomedullary contrast ratio (CMR = signal intensity (SI) of cortex / SI of medulla)) and inverted TI value (value of TI that inverts the renal cortex and renal medulla SI) on steady-state free precession (SSFP) with inversion recovery (IR) pulse with multi TI (TI = 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800 msec) (Fig. 1). A total 21 parameters were compared between healthy groups and early DN group.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2018 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
As of October 25, 2020, MRI was performed after obtaining consent from 28 patients with diabetic nephropathy.
As of October 26, 2022, MRI was performed after obtaining consent from 99 patients with diabetic nephropathy.
Management information
Registered date
| 2018 | Year | 10 | Month | 23 | Day |
Last modified on
| 2024 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039456
