UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008264 |
|---|---|
| Receipt number | R000009740 |
| Scientific Title | The effect of eradication of H.pylori in diabetic patient: a prospective study |
| Date of disclosure of the study information | 2012/07/01 |
| Last modified on | 2017/09/29 18:28:31 |
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Basic information
Public title
The effect of eradication of H.pylori in diabetic patient: a prospective study
Acronym
EPiD study
Scientific Title
The effect of eradication of H.pylori in diabetic patient: a prospective study
Scientific Title:Acronym
EPiD study
Region
| Japan |
Condition
Condition
Diabetes Mellitus
Classification by specialty
| Gastroenterology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of H.pylori eradication in diabetes patient,especially about insulin resistance,visceral fat and other factor of metabolic syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Insulin resistance
Key secondary outcomes
viscral fat
calorie intake
adiponectin,leptin,and lipid
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
H.pyroi eradication
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
type2 diabetes mellitus
Key exclusion criteria
Insulin user
Post gastric surgery
Cancer patient
Severe disoreder of liver of kidney
Post eradication
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Sakurai |
Organization
National Center for Global Health and Medicine (NCGM)
Division name
Gastroenterology and Hepatology
Zip code
Address
1-21-1 Toyama,Shinjuku-ku,Tokyo,Japan
TEL
03-3202-7181
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Sakurai |
Organization
National Center for Global Health and Medicine (NCGM)
Division name
Gastroenterology and Hepatology
Zip code
Address
1-21-1 Toyama,Shinjuku-ku,Tokyo,Japan
TEL
03-3202-7181
Homepage URL
tsakurai@hosp.ncgm.go.jp
Sponsor or person
Institute
The department of Gastroenterology and Hepatology. National Center for Global Health and Medicine (NCGM)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
国立国際医療研究センター(NCGM)
Other administrative information
Date of disclosure of the study information
| 2012 | 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
| 2011 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 26 | Day |
Last modified on
| 2017 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009740
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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