UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023326 |
|---|---|
| Receipt number | R000026877 |
| Scientific Title | Novel regression equations that predicts spirometric parameters in Japanese adults with adiposity including overweight and obesity |
| Date of disclosure of the study information | 2016/07/25 |
| Last modified on | 2018/01/27 00:28:47 |
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Basic information
Public title
Novel regression equations that predicts spirometric parameters in Japanese adults with adiposity including overweight and obesity
Acronym
Novel regression equations for adipotic adluts
Scientific Title
Novel regression equations that predicts spirometric parameters in Japanese adults with adiposity including overweight and obesity
Scientific Title:Acronym
Novel regression equations for adipotic adluts
Region
| Japan |
Condition
Condition
Adipotic adults with no respiratory illness
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop novel regression equations predicting reference means and lower limits of normal of various spirometric parameters in adults with adiposity
Basic objectives2
Others
Basic objectives -Others
To elucidate the qualitative and quantitative differences between the regression equations constructed for the adipotic adults and those previously established for the non-obese adults
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proposal of novel regression equations predicting normal values of spirometric parameters, which are specifically applicable to adipotic adults
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Nonsmoking adults
BMI: more than 25 kg/m2
Key exclusion criteria
Smokers including past smokers
Any respiratory disease
Cardiovascular diseases
Systemic diseases such as malignancy in any organ, renal failure that required dialysis, and diabetes with insulin therapy
No or unacceptable traces of forced expiratory flow-volume curves
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Yamaguchi |
Organization
Tokyo Women's Medical UNiversity
Division name
Comprehensive Medical Center of Sleep Disorders
Zip code
Address
8-1 Kawata-cho, Shinjuku-ku, Tokyo 162-8666, Japan
TEL
03-3353-8111
yamaguc@sirius.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Yamaguchi |
Organization
Tokyo Women's Medical University
Division name
Comprehensive Medical Center of Sleep Disorders
Zip code
Address
8-1 Kawata-cho, Shinjuku-ku, Tokyo 162-8666, Japan
TEL
03-3353-8111
Homepage URL
yamaguc@sirius.ocn.ne.jp
Sponsor or person
Institute
Comprehensive Medical Center of Sleep Disorders, Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Comprehensive Medical Center of Sleep Disorders, Tokyo Women's Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Biomedical Laboratory Sciences, Kumamoto University
Health Care Center, Japanese Red Cross Kumamoto
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京女子医科大学睡眠総合診療センター
熊本大学生物医学研究科
日本赤十字社熊本健康管理センター
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 25 | 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
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 12 | Month | 01 | Day |
Other
Other related information
Subjects: Nonsmoking, adipotic, Japanese adults with no obvious respiratory illness undergoing medical checkups at the Japanese Red Cross Kumamoto Health Care Center.
Explanatory variables: age, height, body weight, and fat fraction of body mass.
Explanatory variables are assumed to be
age-specific.
Proposal of gender-specific regression equations.
Management information
Registered date
| 2016 | Year | 07 | Month | 25 | Day |
Last modified on
| 2018 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026877
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
