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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015146
Receipt No. R000017607
Scientific Title Study of human biogas on glucose and lipid metabolism
Date of disclosure of the study information 2014/09/12
Last modified on 2018/09/17

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Basic information
Public title Study of human biogas on glucose and lipid metabolism
Acronym Human biogas on metabolism
Scientific Title Study of human biogas on glucose and lipid metabolism
Scientific Title:Acronym Human biogas on metabolism
Region
Japan

Condition
Condition healthy voluneteer and patients with glucose impairment who are not receiving any therapeutic agents.
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the relationship between glucose/lipid metabolism and biogas.
Basic objectives2 Others
Basic objectives -Others translational and explorational research / Biogas within sample captured from fore arm or breath will be analysed by a high-throuput gas chromatography with orally loading 13C-labeled glucose or fatty acids.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Identification of the biogas elements that correlate to glucose/lipid metabolism
Key secondary outcomes Identification of the biogas elements that correlate to oxidative stree markers

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
75 years-old >
Gender Male and Female
Key inclusion criteria individuals without any medication at the baseline
Key exclusion criteria history of surgical operation on stomach and small intestine
alcoholism
smoker
malignancy
dementia
severe
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Sasaki
Organization The Jikei University School of Medicine
Division name Institute of Clinical Medicine and Research
Zip code
Address 163-1, Kashiwashita, Kashiwa, Chiba, 277-8567, Japan
TEL 0471641111
Email tsasaki53@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Sasaki
Organization The Jikei University School of Medicine
Division name Institute of Clinical Medicine and Research
Zip code
Address 163-1, Kashiwashita, Kashiwa, Chiba, 277-8567, Japan
TEL 0471641111
Homepage URL http://www.jikei.ac.jp/univ/gradu/rsch/06_11.html
Email takashi_sasaki@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

Funding Source
Organization The Jikei University School of Medicine

Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Canon Inc.
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 東京慈恵会医科大学附属柏病院

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 12 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2014 Year 09 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 07 Day
Last follow-up date
2015 Year 10 Month 31 Day
Date of closure to data entry
2015 Year 12 Month 31 Day
Date trial data considered complete
2016 Year 01 Month 31 Day
Date analysis concluded
2016 Year 02 Month 28 Day

Other
Other related information Any candidate can be eligible and will be subject to sampling for glycolipid metabolism. It does not specify a case-control.
Biogas will be analyzed in order to investigate the relationship between the gas elements and metabolic status by a dynamic study over time after 13C-glucose in the blood, The unknown but notable elementsd can be identified by referring to known libraries.

Management information
Registered date
2014 Year 09 Month 12 Day
Last modified on
2018 Year 09 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017607

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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