UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017309 |
|---|---|
| Receipt number | R000020070 |
| Scientific Title | a prospective cohort sutdy about prognosis in type 2 diabetes patients |
| Date of disclosure of the study information | 2015/05/15 |
| Last modified on | 2025/05/06 14:55:49 |
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Basic information
Public title
a prospective cohort sutdy about prognosis in type 2 diabetes patients
Acronym
Nishinomiya study
Scientific Title
a prospective cohort sutdy about prognosis in type 2 diabetes patients
Scientific Title:Acronym
Nishinomiya study
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We follow up type 2 diabetes patients prospectively and evaluate associataion between type 2 diabetes with or without metabolic syndrome and gastroenterological cancer.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
incidence of gastroenterological cancer
Key secondary outcomes
incidence of cardiovascular disease
progression of diabetic nephropathy
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes patients who see a doctor regularly
Key exclusion criteria
Patient on dialysis
Patient who are judged ineligible by physician
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Okita |
Organization
Hyogo Prefectural Nishinomiya Hospital
Division name
Department of internal medicine
Zip code
662-0918
Address
Rokutanjicho 13-9, Nishinomiya City, Hyogo, Japan
TEL
0798-34-5151
okitakou5@gmail.com
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Yoshikawa |
Organization
Hyogo Prefectural Nishinomiya Hospital
Division name
Department of internal medicine
Zip code
662-0918
Address
Rokutanjicho 13-9, Nishinomiya City, Hyogo, Japan
TEL
0798-34-5151
Homepage URL
atsushida2002@yahoo.co.jp
Sponsor or person
Institute
Hyogo Prefectural Nishinomiya 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
Hyogo Prefectural Nishinomiya Hospital
Address
Rokutanjicho 13-9, Nishinomiya City, Hyogo, Japan
Tel
0798-34-5151
kennishi-chiken@hp.pref.hyogo.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
兵庫県立西宮病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
https://www.nishihosp.nishinomiya.hyogo.jp/about/rinshou_kenkyu/optout/
Publication of results
Partially published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/tonyobyo/67/Suppl/67_S-167/_article/-char/ja/
Number of participants that the trial has enrolled
5212
Results
A total of 411 individuals developed cancer (293 men and 118 women). Multivariate Cox proportional hazards regression analysis demonstrated that, among men, advanced age and abdominal obesity were significantly associated with an increased risk of cancer (P < 0.0001 and P < 0.01, respectively). In women, general obesity, as indicated by higher BMI, was significantly associated with an elevated cancer risk (P < 0.05).
Results date posted
| 2025 | Year | 05 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 5,212 patients with type 2 diabetes mellitus receiving outpatient treatment were included in the analysis (3,136 men and 2,076 women).
Participant flow
A total of 5,212 patients were enrolled in the study, with no exclusions. During the follow-up period, 1,112 patients became lost to follow-up due to reasons such as relocation, discontinuation of outpatient visits, or death. Patients who were lost to follow-up were included in the analysis for the duration they were under observation.
Adverse events
none
Outcome measures
We prospectively investigated the association between cancer incidence and differences in clinical characteristics, including the use of antidiabetic medications.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We regularly follow up type 2 diabetes patients within the routine care
Management information
Registered date
| 2015 | Year | 04 | Month | 28 | Day |
Last modified on
| 2025 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020070
