UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005807 |
|---|---|
| Receipt number | R000005902 |
| 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. |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2021/07/26 07:17:38 |
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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
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
washi@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Medical Center Omori Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005902
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
