UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000050260