UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010145 |
|---|---|
| Receipt number | R000011881 |
| Scientific Title | Glucose administration to type 2 diabetics influences metabolism during operation |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2018/06/27 13:20:15 |
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Basic information
Public title
Glucose administration to type 2 diabetics influences metabolism during operation
Acronym
Glucose administration to type 2 diabetics influences metabolism during operation
Scientific Title
Glucose administration to type 2 diabetics influences metabolism during operation
Scientific Title:Acronym
Glucose administration to type 2 diabetics influences metabolism during operation
Region
| Japan |
Condition
Condition
Type 2 diabetics undergoing surgery of body surface under general anesthesia
Classification by specialty
| Ophthalmology | Oto-rhino-laryngology | Anesthesiology |
| Plastic surgery | Aesthetic surgery | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the influence on metabolism by glucose administration or not to type 2 diabetics undergoing surgery of body surface
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood concentration of total ketone body, the ratio of blood concentration of ketone body
Blood concentration of free fatty acid
Blood concentration of 3-methylhistidine
Blood concentration of creatinine
Blood concentration of glucose
Blood concentration of insulin
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Infuse only bicarbonate Ringer's solution during general anesthesia
Interventions/Control_2
Infuse bicarbonate Ringer's solution and a small mount of glucose during general anesthesia
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type 2 diatetics undergoing surgery of body surface under general anesthesia
Key exclusion criteria
ASA physical status >=3
diabetics using insulin, diabetics who have poor control of blood-sugar levels, neurologic disease, thyroid disease, renal disorder, liver disorder, emaciation(BMI<=17), obesity(BMI>=30)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriko Niki |
Organization
Tokushima University Hospital
Division name
Department of Anesthesiology
Zip code
Address
50-1, 2cho-me, Kuramoto Town, Tokushima City, Tokushima, Japan
TEL
088-633-7181
norikokambe@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Niki |
Organization
Tokushima University Hospital
Division name
Department of Anesthesiology
Zip code
Address
50-1, 2cho-me, Kuramoto Town, Tokushima City, Tokushima, Japan
TEL
088-633-7181
Homepage URL
norikokambe@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokushima University Faculty of medicine, Department of Anesthesiology
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
Address
Tel
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
| 2013 | Year | 04 | 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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 01 | Day |
Last modified on
| 2018 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011881
