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 2024/01/08 09:33:31

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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 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

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

2024 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

2024 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name