UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024731
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email m-keika@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028447

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.