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 |
* 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
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
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
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
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
