UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of human biogas on glucose and lipid metabolism
Title of the study (Brief title)	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	Takashi Sasaki
Organization	The Jikei University School of Medicine
Division name	Institute of Clinical Medicine and Research
Address	163-1, Kashiwashita, Kashiwa, Chiba, 277-8567, Japan
TEL	0471641111
Email	tsasaki53@gmail.com

Public contact
Name of contact person	Takashi Sasaki
Organization	The Jikei University School of Medicine
Division name	Institute of Clinical Medicine and Research
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000017607