UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043264
Receipt number R000049380
Scientific Title Constipation is frequent and associated with vascular complications in patients with type 2 diabetes
Date of disclosure of the study information 2021/02/06
Last modified on 2024/01/09 12:11:47

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Basic information

Public title

Constipation is frequent and associated with vascular complications in patients with type 2 diabetes

Acronym

Type 2 diabetes and constipation

Scientific Title

Constipation is frequent and associated with vascular complications in patients with type 2 diabetes

Scientific Title:Acronym

Type 2 diabetes and constipation

Region

Japan


Condition

Condition

Type 2 diabetes

Classification by specialty

Medicine in general Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the current status of constipation and the association with vascular complications in patients with type 2 diabetes

Basic objectives2

Others

Basic objectives -Others

none

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Frequency of constipation and association with vascular complications

Key secondary outcomes



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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Type 2 diabetic patients with intact ADL and without impaired cognitive function

Key exclusion criteria

Type 2 diabetic patients with disturbed ADL or with impaired cognitive function

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Hiroyuki
Middle name
Last name Ito

Organization

Edogawa Hospital

Division name

Department of Diabetes, Metabolism and Kidney Disease

Zip code

133-0052

Address

2-24-18, Higashikoiwa, Edogawa, Tokyo

TEL

03-3673-1221

Email

ito@edogawa.or.jp


Public contact

Name of contact person

1st name Hiroyuki
Middle name
Last name Ito

Organization

Edogawa Hospital

Division name

Department of Diabetes, Metabolism and Kidney Disease

Zip code

133-0052

Address

2-24-18, Higashikoiwa, Edogawa, Tokyo

TEL

03-3673-1221

Homepage URL


Email

ito@edogawa.or.jp


Sponsor or person

Institute

Edogawa Hospital

Institute

Department

Personal name



Funding Source

Organization

none

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

Edogawa Hospital

Address

2-24-18, Higashikoiwa, Edogawa, Tokyo

Tel

03-3673-1221

Email

ito@edogawa.or.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

2021 Year 02 Month 06 Day


Related information

URL releasing protocol

https://www.jstage.jst.go.jp/article/internalmedicine/61/9/61_7676-21/_article

Publication of results

Published


Result

URL related to results and publications

https://www.jstage.jst.go.jp/article/internalmedicine/61/9/61_7676-21/_article

Number of participants that the trial has enrolled

410

Results

The prevalence of chronic constipation was found in 36%. Patients with constipation were significantly older and had a longer duration of diabetes than those without. The BMI of patients with constipation was significantly lower than that of those without constipation. Diabetic neuropathy and CHD were significantly more frequent in the patients with constipation than in those without constipation. The gender, BMI, diabetic neuropathy, insulin use, and CHD were significantly associated with constipation.

Results date posted

2024 Year 01 Month 09 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

410 patients with type 2 diabetes

Participant flow

410 patients with type 2 diabetes

Adverse events

N/A

Outcome measures

Prevalence of constipation

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2019 Year 06 Month 01 Day

Date of IRB

2019 Year 08 Month 05 Day

Anticipated trial start date

2019 Year 08 Month 05 Day

Last follow-up date

2020 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Cross-sectional study


Management information

Registered date

2021 Year 02 Month 06 Day

Last modified on

2024 Year 01 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049380


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name