UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026592
Receipt number R000030526
Scientific Title Relationships of Gut Microbiota with Obesity and Effects of Therapeutic Intervention in Japanese Obese Patients
Date of disclosure of the study information 2017/03/17
Last modified on 2017/09/16 19:06:21

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Basic information

Public title

Relationships of Gut Microbiota with Obesity and Effects of Therapeutic Intervention in Japanese Obese Patients

Acronym

G-METEO Study

Scientific Title

Relationships of Gut Microbiota with Obesity and Effects of Therapeutic Intervention in Japanese Obese Patients

Scientific Title:Acronym

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

1st name
Middle name
Last name Noriko Asahara

Organization

National Hospital Organization Kyoto medical center

Division name

Department of Endocrinology, Metabolism, and, Hypertension Clinical Research Institute

Zip code


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

1st name
Middle name
Last name Noriko Asahara

Organization

National Hospital Organization Kyoto medical center

Division name

Department of Endocrinology, Metabolism, and, Hypertension Clinical Research Institute

Zip code


Address

1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto

TEL

075-641-9161

Homepage URL


Email

nsatoh@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

National Hospital Organization Kyoto medical center

Institute

Department

Personal name



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)



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

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


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

No longer recruiting

Date of protocol fixation

2015 Year 03 Month 09 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030526


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name