UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022994 |
|---|---|
| Receipt number | 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 21:36:05 |
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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
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
yamadae@nanbu.saiseikai.or.jp
Sponsor or person
Institute
Saiseikai Yokohamashi Nanbu Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026503
