UMIN-CTR Clinical Trial

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
Email	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
Email	hitoshi@nms.ac.jp

Sponsor
Institute	Graduate School of Medicine, Nippon Medical School
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042448