UMIN-CTR Clinical Trial

Basic information
Public title	Association between hypoglycemia after gastrectomy and postoperative cognitive dysfunction in elderly patients
Acronym	Association between hypoglycemia after gastrectomy and postoperative cognitive dysfunction in elderly patients
Scientific Title	Association between hypoglycemia after gastrectomy and postoperative cognitive dysfunction in elderly patients
Scientific Title:Acronym	Association between hypoglycemia after gastrectomy and postoperative cognitive dysfunction in elderly patients
Region	Japan

Condition
Condition	Gastric Cancer
Classification by specialty	Gastrointestinal surgery Not applicable Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Association between hypoglycemia after gastrectomy and postoperative cognitive dysfunction in elderly patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation coefficient between % time of<70 mg/dL and the cognitive dysfunction at 12 months after surgery
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Continuous glucose monitoring for 14 days three times
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients who are histologically proven gastric adenocarcinoma 2) Patients who are diagnosed esophageal invasion within 3 cm 3) Age upon enrollment is over 65 years 4) Patients who receive gastrectomy 5) Patients who receive informed consent
Key exclusion criteria	1) Synchronous or metachronous malignancies other than carcinoma in situ 2) Patients who have cardiac pacemakers implantation 3) Doctors decision not to register to this trial
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yasuhiro Middle name Last name Kodera
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
Zip code	4668550
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL	0527442250
Email	ykodera@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Chie Middle name Last name Tanaka
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
Zip code	4668550
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL	0527442250
Homepage URL
Email	chtanaka@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Japan Society for the promotion of Science
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	Institutional Review Board of the Ethics Committee of Nagoya University School of Medicine
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
Tel	052-744-2061
Email	ethics@med.nagoya-u.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	2021 Year 10 Month 01 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	Preinitiation
Date of protocol fixation	2021 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2021 Year 10 Month 01 Day
Last follow-up date	2027 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 06 Month 07 Day
Last modified on	2021 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050783