UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024983 |
|---|---|
| Receipt number | R000028750 |
| Scientific Title | Evaluation of blood sugar level after preoperative oral rehydration by the carbohydrate-containing fluids for diabetes patients used with current oral hypoglycemic agents |
| Date of disclosure of the study information | 2016/11/29 |
| Last modified on | 2023/05/31 11:14:46 |
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Basic information
Public title
Evaluation of blood sugar level after preoperative oral rehydration by the carbohydrate-containing fluids for diabetes patients used with current oral hypoglycemic agents
Acronym
Preoperative ORT for DM patients used with current oral hypoglycemic agents
Scientific Title
Evaluation of blood sugar level after preoperative oral rehydration by the carbohydrate-containing fluids for diabetes patients used with current oral hypoglycemic agents
Scientific Title:Acronym
Preoperative ORT for DM patients used with current oral hypoglycemic agents
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the blood sugar level of diabetes patients undergoing elective surgery after oral rehydration by the carbohydrate-containing fluids when the patients take BG, TZD derivatives, alpha-GI or DPP-4 inhibitor on the morning of surgical day if the patients have been taken them currently.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether blood sugar levels at arriving to the operating room significant decrease compared with when diabetes patients have been taken no current oral hypoglycemic agents on the morning of surgical day.
Key secondary outcomes
no symptoms of hypoglycemia during awating period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
If diabetes patients undergoing elective surgery have been taken BG, TZD derivatives, alpha-GI or DPP-4 inhibitor currently, the patients take these four kinds of current oral hypoglycemic agents on the morning of surgical day.
Interventions/Control_2
Diabetes patients undergoing elective surgery take no current oral hypoglycemic agents on the morning of surgical day.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
diabetes patients undergoing elective surgery treated with oral hypoglycemic drugs currently
Key exclusion criteria
1)insulin-treated patients
2)HbA1c>=8.0
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Kasama |
Organization
Nagano Prefectural Rehabilitation Center
Division name
Department of anesthesiology
Zip code
381-8577
Address
618-1 Shimokomazawa, Nagano City, Nagano, Japan
TEL
026-296-3953
ksmassmu@plum.plala.or.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Kasama |
Organization
Nagano Prefectural Rehabilitation Center
Division name
Department of anesthesiology
Zip code
381-8577
Address
618-1 Shimokomazawa, Nagano City, Nagano, Japan
TEL
026-296-3953
Homepage URL
ksmassmu@plum.plala.or.jp
Sponsor or person
Institute
Nagano Prefectural Rehabilitation Center
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
Nagano Prefectural Rehabilitation Center
Address
618-1 Shimokomazawa, Nagano City, Nagano, Japan
Tel
026-296-3953
rehabili@pref.nagano.lg.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
| 2016 | Year | 11 | Month | 29 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2028 | Year | 03 | 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
| 2016 | Year | 11 | Month | 24 | Day |
Last modified on
| 2023 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028750
