UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037360 |
|---|---|
| Receipt number | R000042448 |
| Scientific Title | Associations with changes of QTc interval and other clinical parameters in patients with type 2 diabetes |
| Date of disclosure of the study information | 2019/07/16 |
| Last modified on | 2021/06/09 17:51:24 |
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Basic information
Public title
Associations with changes of QTc interval and other clinical parameters in patients with type 2 diabetes
Acronym
Associations with changes of QTc interval and other clinical parameters in patients with type 2 diabetes
Scientific Title
Associations with changes of QTc interval and other clinical parameters in patients with type 2 diabetes
Scientific Title:Acronym
Associations with changes of QTc interval and other clinical parameters 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 changes of QT interval and other clinical parameters in patients with type 2 diabetes
Basic objectives2
Others
Basic objectives -Others
changes of QTc interval in patients with type 2 diabetes
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QTc interval
Key secondary outcomes
blood glucose, glycated albumin, glycated hemoglobin
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
| 80 | 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 January 2014 - December 2014.
Key exclusion criteria
atrial fibrillation, uncontrolled endocrine disease, receiving steroid therapy, hemodialysis, infection, malignant tumor under treatment and ketoacidosis.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Sugihara |
Organization
Graduate School of Medicine, Nippon Medical School
Division name
Department of Endocrinology, Diabetes and Metabolism
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
03-3822-2131
hitoshi@nms.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Sugihara |
Organization
Graduate School of Medicine, Nippon Medical School
Division name
Department of Endocrinology, Diabetes and Metabolism
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
03-3822-2131
Homepage URL
hitoshi@nms.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine, Nippon Medical School
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, 113-8603, 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
| 2019 | Year | 07 | Month | 16 | Day |
Related information
URL releasing protocol
https://doi.org/10.1177/20420188211010057
Publication of results
Unpublished
Result
URL related to results and publications
https://doi.org/10.1177/20420188211010057
Number of participants that the trial has enrolled
34
Results
QTc was shortened from 439ms to 427ms during hospitalization.
changes in QTc was positively correlated with the changes in fasting plasma glucose and glycated albumin following insulin therapy, but not with the final dose of insulin.
The multiple regression analyses revealed that changes in FPG was independently associated with changes in QTc.
Results date posted
| 2021 | Year | 06 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
mean age 61 years, mean HbA1c at admission 10.4%, mean QTc at admission 439ms
Participant flow
none
Adverse events
none
Outcome measures
QTc at admission and discharge
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | 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
retrospective review
Management information
Registered date
| 2019 | Year | 07 | Month | 13 | Day |
Last modified on
| 2021 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042448
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| Registered date | File name |
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