UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of gastric transit time after ingestion of different volume of isocalorically-adjuted glucose solution by ultrasound assessment of gastric volume.
Title of the study (Brief title)	Comparison of gastric transit time after ingestion of different volume of isocalorically-adjuted glucose solution by ultrasound assessment of gastric volume.
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the difference of gastric transit time after ingestion of different volume of isocalorically-adjuted glucose solution.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The cross-sectional surface area of the gastric antrum measured by ultrasound
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	The change of the cross-sectional surface area of the gastric antrum with time after after ingestion of 400ml of 12.5% glucose solution.
Interventions/Control_2	The change of the cross-sectional surface area of the gastric antrum with time after after ingestion of 400ml of 25% glucose solution.
Interventions/Control_3	The change of the cross-sectional surface area of the gastric antrum with time after after ingestion of 600ml of 8.3% glucose solution.
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	Persons who fills everything the following 1) a person of 20years or more 2) a person who gives written informed consent
Key exclusion criteria	1. a person who have gastrointestinal lesion. 2. a person who are ineligible in the opinion of the investigator.
Target sample size	10

Research contact person
Name of lead principal investigator	Tadashi Okabe
Organization	Hitachi, Ltd. Hitachinaka General Hospital
Division name	Department of Anesthesiology
Address	20-1 Ishikawa-cho Hitachinaka-shi Ibaraki 312-0057 JAPAN
TEL	029-354-5111
Email	t-okabe@nms.ac.jp

Public contact
Name of contact person	Tadashi Okabe
Organization	Hitachi, Ltd. Hitachinaka General Hospital
Division name	Department of Anesthesiology
Address	20-1 Ishikawa-cho Hitachinaka-shi Ibaraki 312-0057 JAPAN
TEL	029-354-5111
Homepage URL
Email	t-okabe@nms.ac.jp

Sponsor
Institute	Hitachi, Ltd. Hitachinaka General Hospital
Institute
Department

Funding Source
Organization	None
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

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 02 Day
Anticipated trial start date	2014 Year 08 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 08 Month 23 Day
Last modified on	2016 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017373