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Name
UMIN ID

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000046558
Receipt No. R000053114
Scientific Title Study on clinical signs and biomarkers of diabetic polyneuropathy (DPN)
Date of disclosure of the study information 2022/01/11
Last modified on 2022/01/06

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Basic information
Public title Study on clinical signs and biomarkers of diabetic polyneuropathy (DPN)
Acronym Study on clinical signs and biomarkers of diabetic polyneuropathy (DPN)
Scientific Title Study on clinical signs and biomarkers of diabetic polyneuropathy (DPN)
Scientific Title:Acronym Study on clinical signs and biomarkers of diabetic polyneuropathy (DPN)
Region
Japan

Condition
Condition diabetic polyneuropathy
Classification by specialty
Endocrinology and Metabolism Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the relationship between clinical symptoms and plasma biomarker concentration in diabetic polyneuropathy.
In addition, the relationship between plasma biomarker concentration and clinical symptoms will be investigated in more detail, including DPN patients without subjective symptoms and diabetic patients without DPN (non-DPN).
Basic objectives2 Others
Basic objectives -Others Observational research
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes 1.modified Tront Clinical Neuropathy Score
2. plasma biomarker concentration
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 1. Type 1 and type 2 diabetic patients whose presence or absence of neuropathy was determined by simplified diagnostic criteria for diabetic polyneuropathy
2. Japanese adult men and women
3. Patients who can evaluate mTCNS
4. Patients with HbA1c value of 10.0% or less
5. Patients who have written consent to participate in this study
Key exclusion criteria 1. Patients with non-diabetic peripheral neuropathy
2. Patients with pain symptoms other than DPN in the lower limbs
3. Patients with overt central neurodegenerative disease (dementia, acute cerebral infarction, etc.)
4. Patients who are judged to have the possibility of changing treatment methods (drug therapy, etc.) for diabetes during the clinical study period
5. Patients judged by the attending physician to be inappropriate for participation in this study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hideki
Middle name
Last name Kamiya
Organization Aichi Medical University School of Medicine
Division name Division of Diabetes, Department of Internal Medicine
Zip code 480-1195
Address 1-1 Yazakokarimata, Nagakute, Aichi
TEL 0561-63-1683
Email hkamiya@aichi-med-u.ac.jp

Public contact
Name of contact person
1st name Tatsuhito
Middle name
Last name Himeno
Organization Aichi Medical University School of Medicine
Division name Division of Diabetes, Department of Internal Medicine
Zip code 480-1195
Address 1-1 Yazakokarimata, Nagakute, Aichi
TEL 0561-63-1683
Homepage URL
Email thimeno@aichi-med-u.ac.jp

Sponsor
Institute Division of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine
Institute
Department

Funding Source
Organization ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Aichi Medical University School of Medicine
Address 1-1 Yazakokarimata, Nagakute, Aichi
Tel 0561-63-1683
Email thimeno@aichi-med-u.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
2022 Year 01 Month 11 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
2020 Year 07 Month 16 Day
Date of IRB
2020 Year 09 Month 25 Day
Anticipated trial start date
2020 Year 12 Month 22 Day
Last follow-up date
2023 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2023 Year 10 Month 31 Day

Other
Other related information Research design: cross sectional study
Recruitment: offer to each participant

Management information
Registered date
2022 Year 01 Month 06 Day
Last modified on
2022 Year 01 Month 06 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053114

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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