UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048010 |
|---|---|
| Receipt number | R000053091 |
| Scientific Title | Effect of preoperative withdrawal of SGLT2 inhibitors on the development of perioperative euglycemic ketoacidosis in diabetic patients taking SGLT2 inhibitors |
| Date of disclosure of the study information | 2022/06/09 |
| Last modified on | 2022/06/09 17:05:56 |
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Basic information
Public title
Effect of preoperative withdrawal of SGLT2 inhibitors on the development of perioperative euglycemic ketoacidosis in diabetic patients taking SGLT2 inhibitors
Acronym
Effect of preoperative withdrawal of SGLT2 inhibitors on the development of perioperative euglycemic ketoacidosis in diabetic patients taking SGLT2 inhibitors
Scientific Title
Effect of preoperative withdrawal of SGLT2 inhibitors on the development of perioperative euglycemic ketoacidosis in diabetic patients taking SGLT2 inhibitors
Scientific Title:Acronym
Effect of preoperative withdrawal of SGLT2 inhibitors on the development of perioperative euglycemic ketoacidosis in diabetic patients taking SGLT2 inhibitors
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Calculate the incidence of euglycemic ketoacidosis in the perioperative period in diabetic patients who underwent surgery under general anesthesia at our institution, in patients who withdrew SGLT2 inhibitors only on the day of surgery and in patients who withdrew SGLT2
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of perioperative euglycemic ketoacidosis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
diabetic patients
Key exclusion criteria
none
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuna |
| Middle name | |
| Last name | Kawakami |
Organization
Tenri Hospital
Division name
Department of Anesthesia
Zip code
632-8552
Address
200, Mishima-cho, Tenri-shi, Nara, Japan
TEL
0743-63-5611
yuuna.k.14@gmail.com
Public contact
Name of contact person
| 1st name | Yuna |
| Middle name | |
| Last name | Kawakami |
Organization
Tenri Hospital
Division name
Department of Anesthesia
Zip code
632-8552
Address
200, Mishima-cho, Tenri-shi, Nara, Japan
TEL
0743-63-5611
Homepage URL
yuuna.k.14@gmail.com
Sponsor or person
Institute
Department of Anesthesia, Tenri Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tenri Hospital
Address
200, Mishima-cho, Tenri-shi, Nara, Japan
Tel
0743635611
yuuna.k.14@gmail.com
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
天理よろづ相談所病院（奈良県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 09 | Day |
Related information
URL releasing protocol
https://www1.tenriyorozu.jp/tokucho/katsudo/rinri
Publication of results
Partially published
Result
URL related to results and publications
https://www1.tenriyorozu.jp/tokucho/katsudo/rinri
Number of participants that the trial has enrolled
64
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
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 17 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 17 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 17 | Day |
Other
Other related information
retrospective study
Management information
Registered date
| 2022 | Year | 06 | Month | 09 | Day |
Last modified on
| 2022 | 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=R000053091
