UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038750
Receipt number 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 00:39:04

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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 or person

Institute

Asama General Hospital

Institute

Department

Personal name



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

Value
https://center6.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