UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044453 |
|---|---|
| Receipt number | R000050783 |
| Scientific Title | Association between hypoglycemia after gastrectomy and postoperative cognitive dysfunction in elderly patients |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2021/06/07 10:36:58 |
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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
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
chtanaka@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050783
