UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040833 |
|---|---|
| Receipt number | R000046580 |
| Scientific Title | Associations with QTc interval and atherosclerosis in patients with type 2 diabetes |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2023/08/30 13:45:16 |
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Basic information
Public title
Associations with QTc interval and atherosclerosis in patients with type 2 diabetes
Acronym
Associations with QTc interval and atherosclerosis in patients with type 2 diabetes
Scientific Title
Associations with QTc interval and atherosclerosis in patients with type 2 diabetes
Scientific Title:Acronym
Associations with QTc interval and atherosclerosis in patients with type 2 diabetes
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prolonged QTc interval is associated with fatal cardiac arrhythmia and mortality. The aim of this study is to investigate association with QTc interval and atherosclerosis in patients with type 2 diabetes
Basic objectives2
Others
Basic objectives -Others
The aim of this study is to investigate association with QTc interval and atherosclerosis markers such as ABI, CAVI, Carotid artery ultrasonography, FMD in patients with type 2 diabetes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QTc interval, ABI, CAVI, Carotid artery ultrasonography, FMD
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes who were admitted to Nippon Medical School Hospital for glycemic control during April 2009 to March 2013.
Key exclusion criteria
Atrial fibrillation, uncontrolled endocrine disease, receiving steroid therapy, hemodialysis, infection, malignant tumor under treatment and ketoacidosis.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Sugihara |
Organization
Nippon Medical School Hospital
Division name
Department of Diabetes, Endocrinology and Metabolism
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
hitoshi@nms.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Sugihara |
Organization
Nippon Medical School Hospital
Division name
Department of Diabetes, Endocrinology and Metabolism
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
Homepage URL
hitoshi@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School 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
Nippon Medical School hospital
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
Tel
03-3822-2131
inq-ccr@nms.ac.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
| 2020 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
133
Results
Analysis of the correlation between the markers of arteriosclerosis such as ABI, CAVI, carotid mean IMT, carotid max IMT, and FMD and corrected QT interval showed that only FMD had a statistically significant correlation with corrected QT interval. In multiple regression analysis, FMD was also statistically significantly associated with corrected QT interval.
Results date posted
| 2023 | Year | 08 | Month | 30 | Day |
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
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective review
Management information
Registered date
| 2020 | Year | 06 | Month | 19 | Day |
Last modified on
| 2023 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046580
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
