UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051185 |
|---|---|
| Receipt number | R000058197 |
| Scientific Title | Study on the Usefulness of microcirculation images in the treatment of diabetes in patients with diabetic nephropathy. |
| Date of disclosure of the study information | 2023/06/12 |
| Last modified on | 2025/04/02 16:24:58 |
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Basic information
Public title
Study on the Usefulness of microcirculation images in the treatment of diabetes in patients with diabetic nephropathy.
Acronym
SUMMIT-N
Scientific Title
Study on the Usefulness of microcirculation images in the treatment of diabetes in patients with diabetic nephropathy.
Scientific Title:Acronym
SUMMIT-N
Region
| Japan |
Condition
Condition
diabetic nephropathy
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the usefulness of fingertip capillary imaging in the treatment of diabetes in patients with diabetic nephropathy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantitative values of fingertip capillary images
Blood vessel density, capillary shape (length, width, turbidity, thickness, curvature)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.diabetes Mellitus
2.HbA1c 7.0%<=
3.urine protein/creatinine ratio 30mg/gCr<=and <300mg/gCr
4.eGFR 60ml/min/1.73m2<=
5.Aged 20<=
6.Outpatient and Inpatient
7.Any gender
8.Provision of written consent
Key exclusion criteria
1.Acute exacerbation patients with chronic heart failure
2.Within 3 months,stroke,Acute coronary syndrome,And percutaneous coronary angioplasty,coronary artery bypass surgery
3.Severe liver dysfunction(Chronic hepatitis C etc)
4.Concurrent malignancy
5.Concurrent dementia
6.State requiring nursing care (level 4 <=)
7.Pregnancy or possible pregnancy
8.Inappropriateness as a subject
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | KEN |
| Middle name | |
| Last name | SUGIMOTO |
Organization
Kawasaki Medical School
Division name
General Geriatric Medicine
Zip code
701-0192
Address
577 Matsushima, Kurashiki City, Okayama Prefecture,Japan
TEL
086-462-1111
ksugimoto@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | KEN |
| Middle name | |
| Last name | SUGIMOTO |
Organization
Kawasaki Medical School
Division name
General Geriatric Medicine
Zip code
701-0192
Address
577 Matsushima, Kurashiki City, Okayama Prefecture,Japan
TEL
086-462-1111
Homepage URL
ksugimoto@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School ,General Geriatric Medicine
Institute
Department
Personal name
Funding Source
Organization
AT Co.,Ltd
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School ,Ethics committee
Address
577 Matsushima, Kurashiki City, Okayama Prefecture, Japan
Tel
086-464-1076
kenkyu-soudan@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
| 2023 | Year | 06 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2023 | Year | 05 | Month | 29 | Day |
Last modified on
| 2025 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058197
