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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008264
Receipt No. 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

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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
Email

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
Email tsakurai@hosp.ncgm.go.jp

Sponsor
Institute The department of Gastroenterology and Hepatology. National Center for Global Health and Medicine (NCGM)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009740

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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