UMIN-CTR Clinical Trial

Basic information
Public title	cross sectional study for the relationship between adiposity and cathelicidin
Acronym	cross sectional study for the relationship between adiposity and cathelicidin
Scientific Title	cross sectional study for the relationship between adiposity and cathelicidin
Scientific Title:Acronym	cross sectional study for the relationship between adiposity and cathelicidin
Region	Japan

Condition
Condition	Obesity group (subcutaneous fat type obesity group, internal organs fat type obesity group, metabolic syndrome group, the metabolic syndrome group which had a coronary disease) and volunteer group of the normal BMI
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Elucidation about the association between fat accumulation process (from normal BMI to metabolic syndrome) and cathelicidin
Basic objectives2	Others
Basic objectives -Others	Elucidation about the association between fat accumulation process (from normal BMI to metabolic syndrome) and cell free DNA
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	cathelicidin, and cell free DNA in blood
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	Obesity group (subcutaneous fat type obesity group, internal organs fat type obesity group, metabolic syndrome group, the metabolic syndrome group which had a coronary disease) and volunteer group of the normal BMI Patients with written informed consent
Key exclusion criteria	patients judged as inappropriate by the doctor
Target sample size	100

Research contact person
Name of lead principal investigator	1st name MOTOKI Middle name Last name TANIGUCHI
Organization	Wakayama medical university
Division name	department of cardiovascular medicine
Zip code	641-8509
Address	811-1, Kimiidera, Wakayama city
TEL	073-447-2300
Email	motoki@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Motoki Middle name Last name Taniguchi
Organization	Wakayama medical university
Division name	department of cardiovascular medicine
Zip code	641-8509
Address	811-1, Kimiidera, Wakayama city
TEL	073-447-2300
Homepage URL
Email	motoki@wakayama-med.ac.jp

Sponsor
Institute	Wakayama medical university
Institute
Department

Funding Source
Organization	Wakayama medical university
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	Research Ethics Committee of Wakayama Medical University
Address	811-1 Kimiidera, Wakayama, Wakayama Prefecture
Tel	073-447-2300
Email	wa-rinri@wakayama-med.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	2022 Year 05 Month 10 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	Enrolling by invitation
Date of protocol fixation	2022 Year 03 Month 01 Day
Date of IRB	2022 Year 03 Month 31 Day
Anticipated trial start date	2022 Year 06 Month 01 Day
Last follow-up date	2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Elucidation about the association between fat accumulation process from normal BMI to metabolic syndrome and cathelicidin

Management information
Registered date	2022 Year 05 Month 08 Day
Last modified on	2022 Year 05 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054338