UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of intraoperative administration of amino acid on glucose metabolism, protein and fatty catabolism in patient
Title of the study (Brief title)	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	Keika Mukaihara
Organization	Kagoshima University Hospital
Division name	Anesthesiology
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	Keika mukaihara
Organization	Kagoshima University Hospital
Division name	Anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000028447