UMIN-CTR Clinical Trial

Basic information
Public title	Role of growth differentiation factor 11 in physical activity, exercise capacity and systemic inflammation of patients with COPD
Acronym	Role of growth differentiation factor 11 in patients with COPD
Scientific Title	Role of growth differentiation factor 11 in physical activity, exercise capacity and systemic inflammation of patients with COPD
Scientific Title:Acronym	Role of growth differentiation factor 11 in patients with COPD
Region	Japan

Condition
Condition	chronic obstructive pulmonary disease
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the levels of GDF11 in the plasma of patients with COPD and to elucidate the role of GDF11 in physical activity, exercise capacity and systemic inflammation of patients with COPD.
Basic objectives2	Others
Basic objectives -Others	observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluate the expression of GDF11 in COPD patients, and investigate the association with levels of plasma GDF11 with physical activity, exercise capacity and systemic inflammatory markers in patients with COPD.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	COPD patients diagnosed by spirometry and healthy volunteers
Key exclusion criteria	patients and healthy volunteers who deny participating in this study
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Tomohiro Middle name Last name Ichikawa
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Respiratory Medicine
Zip code	980-8574
Address	1-1 Seiryoumachi, Aobaku, Sendai Japan
TEL	022-717-8539
Email	ichikawa@rm.med.tohoku.ac.jp

Public contact
Name of contact person	1st name Tomohiro Middle name Last name Ichikawa
Organization	Tohoku University Graduate Schoolof Medicine
Division name	Department of Respiratory Medicine
Zip code	980-8574
Address	1-1 Seiryoumachi, Aobaku, Sendai Japan
TEL	022-717-8539
Homepage URL
Email	ichikawa@rm.med.tohoku.ac.jp

Sponsor
Institute	Department of Respiratory Medicine, TohokuUniversityGraduateSchoolof Medicine
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tohoku University Graduate School of Medicine
Address	2-1 Seiryoumachi,Aobaku,Sendai Japan
Tel	022-717-8007
Email	med-kenkyo@bureau.tohoku.ac.jp

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 09 Month 20 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
Date of protocol fixation	2015 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date	2015 Year 03 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	study design : cohort study subjects recruitment method : all subjects who admit to our hospital since May 2013 and meet the selection criteria and who apply to pubilic offering. mesurement items : lung function, blood samples,physical activity,exercise capacity

Management information
Registered date	2016 Year 09 Month 20 Day
Last modified on	2020 Year 03 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027751