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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010742
Receipt No. R000012550
Scientific Title Effects of oral carbohydrate beverage on glucose metabolism and preoperative discomforts in oral surgery: a randomized controlled trial
Date of disclosure of the study information 2013/05/16
Last modified on 2016/07/15

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Basic information
Public title Effects of oral carbohydrate beverage on glucose metabolism and preoperative discomforts in oral surgery: a randomized controlled trial
Acronym Effects of preoperative oral carbohydrate beverage
Scientific Title Effects of oral carbohydrate beverage on glucose metabolism and preoperative discomforts in oral surgery: a randomized controlled trial
Scientific Title:Acronym Effects of preoperative oral carbohydrate beverage
Region
Japan

Condition
Condition patients before oral surgery
Classification by specialty
Anesthesiology Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the effects of carbohydrate loading on glucose metabolism.
Basic objectives2 Others
Basic objectives -Others We investigate the effects of carbohydrate loading on decreasing preoperative discomforts.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes serum ketone
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Tap water(control group)
Interventions/Control_2 oral carbohydrate beverage(study group)
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 patients before oral surgery/anesthesia time is more than 3 hours/ASA 1-2/age between 20 and 65 yr/BMI between 18 and 30
Key exclusion criteria diabetes/treatment with cortisone/history of surgery about upper gastrointestinal tract and liver gallbladder/hight risk of aspiration
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Yokoyama
Organization Faculty of dental science, kyushu university
Division name Department of Dental Anesthesiology
Zip code
Address 3-1-1 Maidashi Higashi-ku Fukuoka 812-8582, Japan
TEL 0926426480
Email yokoyama@dent.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Yokoyama
Organization Faculty of dental science, kyushu university
Division name Department of Dental Anesthesiology
Zip code
Address 3-1-1 Maidashi Higashi-ku Fukuoka 812-8582, Japan
TEL 092-642-6480
Homepage URL
Email yokoyama@dent.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Hospital
Institute
Department

Funding Source
Organization Kyushu 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
2013 Year 05 Month 16 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 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 17 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 05 Month 16 Day
Last modified on
2016 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012550

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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