UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010742 |
|---|---|
| Receipt number | 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 17:01:07 |
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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
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
yokoyama@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012550
