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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022994
Receipt No. R000026503
Scientific Title Study about risk factor for abdominal symptom in patients with diabetes mellitus
Date of disclosure of the study information 2016/07/03
Last modified on 2017/03/21

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Basic information
Public title Study about risk factor for abdominal symptom in patients with diabetes mellitus
Acronym Diabetes mellitus and abdominal symptom
Scientific Title Study about risk factor for abdominal symptom in patients with diabetes mellitus
Scientific Title:Acronym Diabetes mellitus and abdominal symptom
Region
Japan

Condition
Condition Diabetes mellitus
Classification by specialty
Medicine in general Gastroenterology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyze risk factors for abdominal symptom in patients with diabetes mellitus
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To analyze risk factors for abdominal symptom in patients with diabetes mellitus
Key secondary outcomes To assess the association between diabetes mellitus and functional abdominal bloating

To assess the association between diabetes mellitus and IBS

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Patient during treatment of diabetes mellitus
Key exclusion criteria 1. Patients with active intra-abdominal and pelvic malignancy
2. Patients with organic gastrointestinal disorders that case abdominal symptoms
3. Patients who is or might be pregnant
4. Patients with dementia or possibly with dementia, or with psychological illness
5. Patients who is determined inappropriate to participate in the study by the attending physician
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Yamada
Organization Saiseikai Yokohamashi Nanbu Hospital
Division name Gastroenterology
Zip code
Address 3-2-10 Kounandai Kounan-ku, Yokohama City, Kanagawa, Japan
TEL 045-832-1111
Email yamadae@nanbu.saiseikai.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Yamada
Organization Saiseikai Yokohamashi Nanbu Hospital
Division name Gastroenterology
Zip code
Address 3-2-10 Kounandai Kounan-ku, Yokohama City, Kanagawa, Japan
TEL 045-832-1111
Homepage URL
Email yamadae@nanbu.saiseikai.or.jp

Sponsor
Institute Saiseikai Yokohamashi Nanbu Hospital
Institute
Department

Funding Source
Organization Saiseikai Yokohamashi Nanbu Hospital
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
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

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 03 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 Completed
Date of protocol fixation
2016 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2017 Year 01 Month 01 Day
Date analysis concluded

Other
Other related information Study Design case-control study

Evaluetion item
GSRS
Japanese Version of the Rome III Diagnostic Questionnaire
SF-8

Management information
Registered date
2016 Year 07 Month 03 Day
Last modified on
2017 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026503

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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