UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031331
Receipt number R000035764
Scientific Title A study to evaluate the inspection process for the oxidation and glycation diagnosis
Date of disclosure of the study information 2018/03/01
Last modified on 2018/05/17 08:58:16

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Basic information

Public title

A study to evaluate the inspection process for the oxidation and glycation diagnosis

Acronym

A study to evaluate the inspection process for the oxidation and glycation diagnosis

Scientific Title

A study to evaluate the inspection process for the oxidation and glycation diagnosis

Scientific Title:Acronym

A study to evaluate the inspection process for the oxidation and glycation diagnosis

Region

Japan


Condition

Condition

Healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate the usefulness of the test method for diagnosing oxidation and glycation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

[1]Correlation of skin AGE accumulation amount calculated for each device
[2]Correlation of blood special examination (AP, OS, pentosidin, CML), CML in stratum corneum and accumulation amount of skin AGEs

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

100 years-old >

Gender

Male and Female

Key inclusion criteria

[1]Aged between 20 and 99
[2]Individuals who are healthy and do not treat any disease
[3]Individuals whose written informed consent has been obtained
[4]Individuals who can have an examination on a designated check day
[5]Individuals judged appropriate for the study by the principal

Key exclusion criteria

[1]Individuals using medical products
[2]Individuals who used a drug to treat in the past 1 month (One-shot medicine of a headache, menstrual pain and a cold removes it.)
[3]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease,or blood disease
[4]Individuals judged inappropriate for the study by the principal

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuji Morita

Organization

SQOL Kanazawa/Urata clinic

Division name

Anti-aging research center

Zip code


Address

3-3-70,Hirooka,Kanazawa-City,Ishikawa,JAPAN

TEL

076-233-6020

Email

morita@hospy.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuji Morita

Organization

SQOL Kanazawa/Urata clinic

Division name

Anti-aging research center

Zip code


Address

3-3-70,Hirooka,Kanazawa-City,Ishikawa,JAPAN

TEL

076-233-6020

Homepage URL


Email

morita@hospy.jp


Sponsor or person

Institute

SQOL Kanazawa/Urata clinic

Institute

Department

Personal name



Funding Source

Organization

SQOL Kanazawa/Urata clinic

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Glycation Stress Research Center,Faculty of Life and Medical Sciences,Doshisha University

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2018 Year 03 Month 01 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

Completed

Date of protocol fixation

2018 Year 01 Month 31 Day

Date of IRB


Anticipated trial start date

2018 Year 03 Month 06 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

For healthy men and women aged 20 years and under 100, subject background investigation (questionnaire form),
Measurement by height / weight / body fat percentage / BMI,skin AGEs accumulation amount measuring machine (AGE Reader su, AGE Reader mu, TruAge, TruAge mini, AGE sensor), general blood / biochemical examination, blood special inspection (antioxidant: AP, Oxidation degree: OS, pentosidine, CML), CML measurement in the stratum corneum by the tape stripping method is carried out.


Management information

Registered date

2018 Year 02 Month 16 Day

Last modified on

2018 Year 05 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035764


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name