UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046558 |
|---|---|
| Receipt number | 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 | 2025/01/08 16:29:20 |
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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
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
thimeno@aichi-med-u.ac.jp
Sponsor or person
Institute
Division of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine
Institute
Department
Personal name
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
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
| 2026 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | 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
| 2025 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053114
