UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of oral carbohydrate beverage on glucose metabolism and preoperative discomforts in oral surgery: a randomized controlled trial
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Takeshi Yokoyama
Organization	Faculty of dental science, kyushu university
Division name	Department of Dental Anesthesiology
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	Takeshi Yokoyama
Organization	Faculty of dental science, kyushu university
Division name	Department of Dental Anesthesiology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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