UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038750
Receipt No. R000044177
Scientific Title Study on improvement of constipation by behavioral therapy in patients of diabetes and obesity
Date of disclosure of the study information 2019/12/01
Last modified on 2019/12/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Study on improvement of constipation by behavioral therapy in patients of diabetes and obesity
Acronym Study on improvement of constipation by behavioral therapy in patients of diabetes and obesity
Scientific Title Study on improvement of constipation by behavioral therapy in patients of diabetes and obesity
Scientific Title:Acronym Study on improvement of constipation by behavioral therapy in patients of diabetes and obesity
Region
Japan

Condition
Condition Patients with diabetes and obesity in Asama General Hospital
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to identify chronic constipation in diabetic and obese patients and to investigate whether constipation can be improved by improving lifestyle.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of defecation frequency and defecation status
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention: Behavior therapy using defecation guidance and defecation diary records
Interventions/Control_2 Control: No behavioral therapy for defecation
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Those who have obtained written consent
Key exclusion criteria Those who are judged inappropriate by research doctors
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Eita
Middle name
Last name Nishimori
Organization Asama General Hospital
Division name Diabetes Medicine
Zip code 385-8558
Address 1862-1 Iwamurada, Saku, Nagano
TEL 0267-67-2295
Email eita-nishimori@umin.ac.jp

Public contact
Name of contact person
1st name Eita
Middle name
Last name Nishimori
Organization Asama General Hospital
Division name Diabetes Medicine
Zip code 385-8558
Address 1862-1, Iwamurada, Saku, Nagano
TEL 0267-67-2295
Homepage URL
Email eita-nishimori@umin.ac.jp

Sponsor
Institute Asama General Hospital
Institute
Department

Funding Source
Organization Asama General Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Asama General Hospital
Address 1862-1, Iwamurada, Saku, Nagano
Tel 0267-67-2295
Email asama-soumu@city.saku.nagano.jp

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
2019 Year 12 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 Enrolling by invitation
Date of protocol fixation
2019 Year 10 Month 18 Day
Date of IRB
2019 Year 10 Month 29 Day
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 12 Month 01 Day
Last modified on
2019 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044177

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.