UMIN-CTR Clinical Trial

Basic information
Public title	The comparative study of the change of blood sugar consentration with feeding by "Inslow(Meiji Co., Ltd.)" or contral formula after surgery for gastric cancer who are Diabetes Mellitus or glucose intolerance.
Acronym	The change of blood sugar consentration with feeding by "Inslow(Meiji Co., Ltd.)" after surgery for gastric cancer.
Scientific Title	The comparative study of the change of blood sugar consentration with feeding by "Inslow(Meiji Co., Ltd.)" or contral formula after surgery for gastric cancer who are Diabetes Mellitus or glucose intolerance.
Scientific Title:Acronym	The change of blood sugar consentration with feeding by "Inslow(Meiji Co., Ltd.)" after surgery for gastric cancer.
Region	Japan

Condition
Condition	The patients who are planed the surgery to gastric cancer with diabetes mellitus or glucose intolerance as 5.9 and over 7.5 and less in HbA1c.
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	a
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1,5-AG
Key secondary outcomes	a

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	a
Interventions/Control_2	a
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	a
Key exclusion criteria	a
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Naohiro Middle name Last name Washizawa
Organization	Toho University Medical Center Omori Hospital
Division name	Nutrition Therapy Center
Zip code	143-8541
Address	6-11-1 Omori-Nishi, Ota-ku, Tokyo, Japan
TEL	0337624151
Email	washi@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Naohiro Middle name Last name Washizawa
Organization	Toho University Medical Center Omori Hospital
Division name	Nutrition Therapy Center
Zip code	143-8541
Address	6-11-1 Omori-Nishi, Ota-ku, Tokyo, Japan
TEL	0337624151
Homepage URL
Email	washi@med.toho-u.ac.jp

Sponsor
Institute	Toho University Medical Center Omori 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)

IRB Contact (For public release)
Organization	Toho University
Address	Omori-Nishi6-11-1, Ota-Ku, Tokyo, Japan
Tel	0337624151
Email	washi@med.toho-u.ac.jp

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	東邦大学医療センター大森病院

Other administrative information
Date of disclosure of the study information	2011 Year 07 Month 01 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	Terminated
Date of protocol fixation	2010 Year 05 Month 01 Day
Date of IRB	2012 Year 03 Month 27 Day
Anticipated trial start date	2011 Year 06 Month 01 Day
Last follow-up date	2021 Year 07 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 06 Month 20 Day
Last modified on	2021 Year 07 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005902