UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Screening for adiponectin secretion using Adipose-derived stem cells in metabolic syndrome
Title of the study (Brief title)	Screening for adiponectin secretion using Adipose-derived stem cells in metabolic syndrome
Region	Japan

Condition
Condition	obesity
Classification by specialty	Endocrinology and Metabolism Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Screening of adiponectin secretion-promoting drugs / foods with adipose derived stem cells (ADSC) that isolated from surgically collected adipose tissue of obese.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adiponectin level in adipocyte culture supernatant
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	1. over BMI25kg/m2 2. Patient undergoing obesity surgery at Osaka University hospital 3. Patient who got written consent from himself / herself
Key exclusion criteria	1. <20 years old 2. Have severe infection 3. pregnant 4. The doctor in charge judges it as inappropriate as a subject.
Target sample size	60

Research contact person
Name of lead principal investigator	Toshinori ITO
Organization	Osaka University Graduate School of Medicine
Division name	Department of Integrative Medicine
Address	2-2, Yamadaoka, Suita, OSAKA
TEL	06-6879-3498
Email	mikity@cam.med.osaka-u.ac.jp

Public contact
Name of contact person	Miki Sakaue
Organization	Osaka University Graduate School of Medicine
Division name	Department of Integrative Medicine
Address	2-2, Yamadaoka, Suita, OSAKA
TEL	06-6879-3498
Homepage URL
Email	mikity@cam.med.osaka-u.ac.jp

Sponsor
Institute	Department of Integrative Medicine, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Integrative Medicine, Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2017 Year 04 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 12 Day
Anticipated trial start date	2015 Year 08 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This study will search for secretagogues of adiponectin in vitro.

Management information
Registered date	2017 Year 04 Month 11 Day
Last modified on	2019 Year 01 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030908