UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study about risk factor for abdominal symptom in patients with diabetes mellitus
Title of the study (Brief title)	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	Eiji Yamada
Organization	Saiseikai Yokohamashi Nanbu Hospital
Division name	Gastroenterology
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	Eiji Yamada
Organization	Saiseikai Yokohamashi Nanbu Hospital
Division name	Gastroenterology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000026503