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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031331
Receipt No. 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

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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
Institute SQOL Kanazawa/Urata clinic
Institute
Department

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
URL(English) https://upload.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


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