UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024731 |
|---|---|
| Receipt number | R000028447 |
| Scientific Title | The effect of intraoperative administration of amino acid on glucose metabolism, protein and fatty catabolism in patient |
| Date of disclosure of the study information | 2016/11/12 |
| Last modified on | 2017/11/21 09:08:12 |
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Basic information
Public title
The effect of intraoperative administration of amino acid on glucose metabolism, protein and fatty catabolism in patient
Acronym
The effect of intraoperative administration of amino acid on glucose metabolism, protein and fatty catabolism in patient
Scientific Title
The effect of intraoperative administration of amino acid on glucose metabolism, protein and fatty catabolism in patient
Scientific Title:Acronym
The effect of intraoperative administration of amino acid on glucose metabolism, protein and fatty catabolism in patient
Region
| Japan |
Condition
Condition
diabetes and non-diabetes
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate whether intraoperative administration of amino acid inhibits catabolism in diabetic and non-diabetic patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diabetic and non-diabetic patients undergoing general anesthesia will be divided into two groups whether or not amino acid is administered intraperatively. The endogenous substances related to glucose metabolism ,protein and fatty catabolism will be measured during surgery.
Key secondary outcomes
Blood pressure,Heart rate,SpO2,BIS,and body temperature during surgery will been measured.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
glucose+amino acid(diabetes)
duration: during operation
dose: glucose 1.5mg/kg/min+ amino acid 100ml/h*2h
blood collection: the start and 3hours after the operation,15ml each
Interventions/Control_2
glucose+amino acid(non-diabetes)
duration: during operation
dose: glucose 1.5mg/kg/min+ amino acid 100ml/h*2h
blood collection: the start and 3hours after the operation,15ml each
Interventions/Control_3
low dose glucose+amino acid(diabetes)
duration: during operation
dose: glucose 0.6mg/kg/min+ amino acid 100ml/h*2h
blood collection: the start and 3hours after the operation,15ml each
Interventions/Control_4
low dose glucose+amino acid(non-diabetes)
duration: during operation
dose: glucose 0.6mg/kg/min+ amino acid 100ml/h*2h
blood collection: the start and 3hours after the operation,15ml each
Interventions/Control_5
glucose(diabetes)
duration: during operation
dose: glucose 1.5mg/kg/min
blood collection: the start and 3hours after the operation,15ml each
Interventions/Control_6
glucose(non-diabetes)
duration: during operation
dose: glucose 1.5mg/kg/min
blood collection: the start and 3hours after the operation,15ml each
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Who undergo lower abdominal viscera operation
Key exclusion criteria
liver dysfunction
kidney dysfunction
cardiac dysfunction
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keika Mukaihara |
Organization
Kagoshima University Hospital
Division name
Anesthesiology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, Japan
TEL
099-275-5430
m-keika@m.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keika mukaihara |
Organization
Kagoshima University Hospital
Division name
Anesthesiology
Zip code
Address
8-35-1 Sakuragaoka,Kagoshima-shi,Kagoshima,Japan
TEL
099-275-5430
Homepage URL
m-keika@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kagoshima University
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
| 2016 | Year | 11 | Month | 12 | 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
| 2016 | Year | 10 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 12 | 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
| 2016 | Year | 11 | Month | 07 | Day |
Last modified on
| 2017 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028447
