UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationships of Gut Microbiota with Obesity and Effects of Therapeutic Intervention in Japanese Obese Patients
Title of the study (Brief title)	G-METEO Study
Region	Japan

Condition
Condition	with or without Obesity
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate 1) the relationship between gut microbiota and obesity and 2) the relationship between the effects of weight reduction therapy on gut microbiota and the efficacy of the therapeutic intervention, by comprehensive analysis of gut microbiota before and after treatment
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Profiles of gut microbiota by 16S rRNA metagenomics
Key secondary outcomes	Bodiy weight, blood pressure, glucose metabolism (HbA1c, FPG, IRI), lipid metabolism (TC, TG, HDL-C, LDL-C)

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	1) Age: more than 20 years old; 2) Gender: male and female; 3) BMI: non-obese, BMI under 25; obese, BMI more than 25; 4) Subjects providing informed consent
Key exclusion criteria	1) Subjects taking reagents which would affect gut microbiota (e.g. antibiotics); 2) Subjects who are judged to be inappropriate for the study by the doctor in charge
Target sample size	120

Research contact person
Name of lead principal investigator	Noriko Asahara
Organization	National Hospital Organization Kyoto medical center
Division name	Department of Endocrinology, Metabolism, and, Hypertension Clinical Research Institute
Address	1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto
TEL	075-641-9161
Email	nsatoh@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Noriko Asahara
Organization	National Hospital Organization Kyoto medical center
Division name	Department of Endocrinology, Metabolism, and, Hypertension Clinical Research Institute
Address	1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto
TEL	075-641-9161
Homepage URL
Email	nsatoh@kuhp.kyoto-u.ac.jp

Sponsor
Institute	National Hospital Organization Kyoto medical center
Institute
Department

Funding Source
Organization	National Hospital Organization Kyoto medical center
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	京都医療センター（京都府）

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 17 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 03 Month 09 Day
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 05 Month 29 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Study design: prospective cohort study Subjects: obese patients who get a check-up at our hospital after January 2016 and meet the inclusion criteria non-obese subjects who get a check-up at our hospital after January 2016 and provide agreement with the study Measurement: hight, waist circumference, liver function (GOT, GPT, gamma-GTP), renal function (BUN, Cre, U-Cre, U-Alb), inflammation (Adiponectin, Leptin, hs-CRP), index of atherosclerosis (CAVI), short chain fatty acids in feces Schedule: at the enrollment and 6 months after the enrollment

Management information
Registered date	2017 Year 03 Month 17 Day
Last modified on	2017 Year 09 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030526