UMIN-CTR Clinical Trial

Basic information
Public title	Clinical significance of metabolite measurement in the perioperative period.
Acronym	Clinical significance of metabolite measurement in the perioperative period.
Scientific Title	Clinical significance of metabolite measurement in the perioperative period.
Scientific Title:Acronym	Clinical significance of metabolite measurement in the perioperative period.
Region	Japan

Condition
Condition	Diabetes
Classification by specialty	Endocrinology and Metabolism Anesthesiology Operative medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will compare the effectiveness of urinary ketone body tests and blood ketone body tests as a method for screening ketosis during the perioperative period.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	Changes in ketones during the perioperative period.
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients scheduled for elective surgery under general anesthesia.
Key exclusion criteria	Epilepsy patients. Patients taking SGLT2 inhibitors without diabetes. Patients with poor control of diabetes (HbA1c >8). Patients who are not scheduled to insert bladder catheter intraoperatively. Without the permission of the attending physician.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Kanji Middle name Last name Uchida
Organization	The university of Tokyo hospital.
Division name	Department of Anesthesiology and Pain Relief Center.
Zip code	1138655
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo.
TEL	0338155411
Email	todai.masuika@gmail.com

Public contact
Name of contact person	1st name Masaki Middle name Last name Iwakiri
Organization	The university of Tokyo hospital.
Division name	Department of Anesthesiology and Pain Relief Center.
Zip code	1138655
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo.
TEL	0338155411
Homepage URL
Email	iwakirim-ane@h.u-tokyo.ac.jp

Sponsor
Institute	The university of Tokyo.
Institute
Department

Funding Source
Organization	The university of Tokyo.
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	Graduate School of Medicine and Faculty of Medicine, The University of Tokyo.
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo.
Tel	0358410818
Email	ethics@m.u-tokyo.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	東京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information	2021 Year 03 Month 18 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	Open public recruiting
Date of protocol fixation	2020 Year 12 Month 24 Day
Date of IRB	2020 Year 12 Month 24 Day
Anticipated trial start date	2021 Year 03 Month 18 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Questionnaire about preoperative condition, Measurement of perioperative ketone bodies and blood glucose levels, Measurement of urinary ketone bodies and urinary sugar after introduction of general anesthesia, Perioperative complications such as diabetic ketoacidosis and Perioperative prognosis.

Management information
Registered date	2021 Year 03 Month 17 Day
Last modified on	2021 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049835