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
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
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
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
