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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044169
Receipt No. 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

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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
Email 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
Email shimojo@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050260

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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