UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037700 |
|---|---|
| Receipt number | R000042997 |
| Scientific Title | Comorbidities Among Japanese Patients with Type 2 Diabetes : a Cross Sectional Survey with J-DREAMS Registry |
| Date of disclosure of the study information | 2019/09/09 |
| Last modified on | 2019/12/10 17:34:12 |
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Basic information
Public title
Comorbidities Among Japanese Patients with Type 2 Diabetes : a Cross Sectional Survey with J-DREAMS Registry
Acronym
Comorbidities Among Japanese Patients with Type 2 Diabetes
Scientific Title
Comorbidities Among Japanese Patients with Type 2 Diabetes : a Cross Sectional Survey with J-DREAMS Registry
Scientific Title:Acronym
a Cross Sectional Survey of comorbidities with J-DREAMS Registry
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comorbidities among patients with diabetes are common and may dictate choice of available therapies. The study examines the prevalence of comorbid conditions that are commonly occur and/or often considered by clinicians when initiating treatment to manage hyperglycemia in patients with type 2 diabetes.
Basic objectives2
Others
Basic objectives -Others
To describe the prevalence and co-prevalence of comorbid conditions among patients with T2DM. Index period to identify eligible patients. All available medical records prior to and including the index date will be examined. Patients background information,the prevalence and co-prevalence of comorbid conditions among patients with T2DM will be evaluated.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To describe the prevalence and co-prevalence of comorbid conditions among patients with T2DM. These conditions include congestive heart failure, chronic kidney disease, retinopathy, neuropathy, cardiovascular disease (coronary artery disease, cerebrovascular disease, and peripheral arterial disease), pancreatitis, liver disease, hypertension, hyperlipidemia, overweight/obesity, amputation, bone fracture, periodontal disease and neoplasm.
Key secondary outcomes
To evaluate the prevalence of the comorbidities stratified by age (<65 years, 65-74 years, >=75 years), gender and duration of T2DM (tertiles).
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Japanese Type 2 diabetic atient with at least one encounter in the database between April 1, 2017 and March 31, 2019
Key exclusion criteria
Patients with type 1 diabetes and any secondary diabetes
Target sample size
15000
Research contact person
Name of lead principal investigator
| 1st name | Kohjiro |
| Middle name | |
| Last name | Ueki |
Organization
Research Institute, National Center for Global Health and Medicine
Division name
Diabetes Research Center
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL
03-3202-7181
j-dreams@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Ohsugi |
Organization
Research Institute, National Center for Global Health and Medicine
Division name
Diabetes and Metabolism Information Center
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL
03-3202-7181
Homepage URL
http://jdreams.jp/
j-dreams@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
MSD K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Health and Medicine
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo
Tel
03-3202-7181
kenkyu-shinsa@hosp.ncgm.go.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 | 09 | Month | 09 | 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 | 07 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To describe the prevalence and co-prevalence of comorbid conditions among patients with T2DM. These conditions include congestive heart failure, chronic kidney disease, retinopathy, neuropathy, cardiovascular disease (coronary artery disease, cerebrovascular disease, and peripheral arterial disease), pancreatitis, liver disease, hypertension, hyperlipidemia, overweight/obesity, amputation, bone fracture, periodontal disease and neoplasm.
Management information
Registered date
| 2019 | Year | 08 | Month | 16 | Day |
Last modified on
| 2019 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042997
