UMIN-CTR Clinical Trial

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