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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000022899
Receipt No. R000024680
Scientific Title The study of the control of postoperative Insulin resistance by preoperative oral carbohydrate and intravenous glucose administration during anesthesia.
Date of disclosure of the study information 2016/06/27
Last modified on 2021/07/02

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Basic information
Public title The study of the control of postoperative Insulin resistance by preoperative oral carbohydrate and intravenous glucose administration during anesthesia.
Acronym The study of the control of postoperative Insulin resistance by preoperative oral carbohydrate and intravenous glucose administration during anesthesia.
Scientific Title The study of the control of postoperative Insulin resistance by preoperative oral carbohydrate and intravenous glucose administration during anesthesia.
Scientific Title:Acronym The study of the control of postoperative Insulin resistance by preoperative oral carbohydrate and intravenous glucose administration during anesthesia.
Region
Japan

Condition
Condition Jaw Deformities
Classification by specialty
Oral surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The study of the control of postoperative Inslin resistance by preoperative oral carbohydrate and intravenous glucose administration during anesthesia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes rate of change of insuline resistance between previous and next day of the operation

Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine Food
Interventions/Control_1 control group:patients drink mineral water before operation and receive acetated Ringer solution without glucose during operation.
Interventions/Control_2 glucose group:patients drink carbohydrate water before operation and receive acetated Ringer solution with 1.5% glucose during operation.
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
50 years-old >=
Gender Male and Female
Key inclusion criteria 1. written informed concent is obtained from jaw deformity patients who undergo osteotomy
2. aged from 20 to 50
3. ASA 1 or 2
4. estimated operation time: more than 3 hours
Key exclusion criteria 1. patients who have any other disorders except for jaw deformity
2. patients diagnosed with diabetes mellitus or disorder of carbohydrate metabolism
3. 18.0>BMI BMI<=30
4. patients whom reseachers consider inappropriate
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Tsukamoto
Organization kyushu university
Division name dental anesthesiology
Zip code
Address 3-1-1 Maidashi Higashi-ku Fukuoka
TEL 092-642-6480
Email tsukamoto@dent.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sayuri Kadowaki
Organization Kyushu university
Division name dental anesthesiology
Zip code
Address 3-1-1 Maidashi Higashi-ku Fukuoka
TEL 092-642-6480
Homepage URL
Email s.koyama@dent.kyushu-u.ac.jp

Sponsor
Institute department of dental anesthesiology, Kyushu university
Institute
Department

Funding Source
Organization Nikkiso Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Nikkiso Co., Ltd.
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 九州大学病院

Other administrative information
Date of disclosure of the study information
2016 Year 06 Month 27 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
2015 Year 10 Month 05 Day
Date of IRB
2015 Year 10 Month 05 Day
Anticipated trial start date
2015 Year 12 Month 07 Day
Last follow-up date
2020 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 06 Month 27 Day
Last modified on
2021 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024680

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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