UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021389 |
|---|---|
| Receipt number | R000024667 |
| Scientific Title | Effects of late-onset hypogonadosm syndrome in prognosis of COPD; prospective, multicenter study |
| Date of disclosure of the study information | 2016/03/09 |
| Last modified on | 2020/02/28 12:03:10 |
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Basic information
Public title
Effects of late-onset hypogonadosm syndrome in prognosis of COPD; prospective, multicenter study
Acronym
Effects of LOH syndrome in prognosis of COPD
Scientific Title
Effects of late-onset hypogonadosm syndrome in prognosis of COPD; prospective, multicenter study
Scientific Title:Acronym
Effects of LOH syndrome in prognosis of COPD
Region
| Japan |
Condition
Condition
COPD stage2-3
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze an effects of LOH syndrome on FEV1 secular change of more than 60-year-old males with COPD in prognosis of COPD. Farther, changes of skeletal muscle weakness, loss of deterioration in nutritional status, body composition, calorific value and quality of life, and the correlation between FEV1 and these factors.
Basic objectives2
Others
Basic objectives -Others
Search of biomarkers
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
secular change of FEV1 with LOH syndrome
Key secondary outcomes
secular change
1.respiratory function(VC, %VC, FVC, FEV1, FEV1%, RV, DLCO)
2.skeletal muscle mass
3.nutritional status(height, weight, BMI, TP, Alb)
4.body composition(body cell mass, body fat, body fat percentage, lean body mass, extracellular intracelullar (TBW), moisture content (ECW))
5.calorific value(basal metabolic rate)
6.inflammation(high-sensitivity CRP)
7.quality of life
8.the correlation between skeletal, muscle mass, nutritional status, body composition, calorific value and quality of life, and FEV1
9.morbidity of LOH syndrome
10.background factor of LOH syndrome
11.effect of LOH syndrome on change of FEV1, skeletal, muscle mass, nutritional status, body composition, calorific value and quality of life
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1)Diagnosed COPD by spirometry
2)Treated for COPD
3)COPD stage2-3
4)More than 60-year-old
5)Male
6)State that patient can visit a hospital
7)Getting the informed consent by patient or amanuensis
Key exclusion criteria
1)Advanced dementia
2)Performed tracheotomy
3)Acute respiratory failure
4)COPD acute exacerbation within 3 months and received oral or intravenous steroid treatment
5)Having a complication of malignancy terminally
6)Female
7)Treated or scheduled androgen therapy
8)Having an interstitial pneumonia and diagnosed with combined pulmonary fibrosis and emphysema
9)Asthma attack within 3 months and received oral or intravenous steroid treatment
10)Treated with home oxygen therapy
11)Reseachers considered not to be suitable for stury
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Ueno |
Organization
National Hospital Organization Takasaki General Medical Center
Division name
Respiratory Medicine
Zip code
Address
36 Takamatsu-cho, Takasaki-city, Gunma
TEL
+81273225901
manabun0825@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Manabu Ueno |
Organization
National Hospital Organization Takasaki General Medical Center
Division name
Respiratory Medicine
Zip code
Address
36 Takamatsu-cho, Takasaki-city, Gunma
TEL
+81273225901
Homepage URL
manabun0825@gmail.com
Sponsor or person
Institute
National Hospital Organization Takasaki General Medical Center
Institute
Department
Personal name
Funding Source
Organization
NHO network study
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 09 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 23 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: prospective cohort study
Subject: patients visited in a hospital during the 2016-2018 and to meet all inclusion criteria
Measurement item: patient information, physical findings, physiological function test, imaging test, laboratory test, muscle measurements, body composition, questionnaire
Management information
Registered date
| 2016 | Year | 03 | Month | 08 | Day |
Last modified on
| 2020 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024667
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
