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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000021389
Receipt No. 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

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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
Email 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
Email manabun0825@gmail.com

Sponsor
Institute National Hospital Organization Takasaki General Medical Center
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024667

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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