UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044169 |
|---|---|
| Receipt number | R000050260 |
| Scientific Title | Association between diabetic neuropathy and abnormality of bone marrow-derived cells in diabetic patients |
| Date of disclosure of the study information | 2021/05/15 |
| Last modified on | 2021/11/24 13:55:54 |
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Basic information
Public title
Association between diabetic neuropathy and abnormality of bone marrow-derived cells in diabetic patients
Acronym
Association between diabetic neuropathy and abnormality of bone marrow-derived cells
Scientific Title
Association between diabetic neuropathy and abnormality of bone marrow-derived cells in diabetic patients
Scientific Title:Acronym
Association between diabetic neuropathy and abnormality of bone marrow-derived cells
Region
| Japan |
Condition
Condition
Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify abnormalities of bone marrow derived cells in diabetic patients
Basic objectives2
Others
Basic objectives -Others
To clarify the pathogenic factors of diabetes and diabetic neuropathy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of peripheral blood bone marrow derived cells and expressed proteins
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetic mellitus
Key exclusion criteria
1) Pregnant and lactating women
2) Patients undergoing treatment for autoimmune diseases or with a history of such diseases
3) Patients undergoing treatment for malignant tumors
4) Patients being treated with steroids or immunosuppressive drugs
5) Patients with type 1 diabetes mellitus
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hideto |
| Middle name | |
| Last name | Kojima |
Organization
Shiga University of Medical Science
Division name
Department of Stem Cell Biology and Regenerative Medicine
Zip code
520-2192
Address
Setatsukinowa-cho, Otsu-City, Shiga, 520-2192, JAPAN
TEL
0775482206
kojima@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Itsuko |
| Middle name | |
| Last name | Miyazawa |
Organization
Shiga University of Medical Science
Division name
Internal medicine
Zip code
520-2192
Address
Setatsukinowa-cho, Otsu-City, Shiga, 520-2192, JAPAN
TEL
0775482222
Homepage URL
shimojo@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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
Shiga University of Medical Science
Address
Setatsukinowa-cho, Otsu-City, Shiga, 520-2192, JAPAN
Tel
0775483576
hqrec@belle.shiga-med.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
| 2021 | Year | 05 | Month | 15 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
The target sample size was re-set after the approval of the I on 2021/11/17. The data in patients with multiple organ failure, which had not been published at the start of the study, were used, but the positive rate of abnormal cells was low in diabetic patients. Using data from 10 patients in each of the exploratory groups, the number of cases required was calculated at 85% power, and it was calculated that 20 patients in each group would be required. We will disclose the reason for the change in the target sample size during the study, and will also mention the change in the sample size of patients when the paper is published.
Management information
Registered date
| 2021 | Year | 05 | Month | 11 | Day |
Last modified on
| 2021 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050260
