UMIN-CTR Clinical Trial

Basic information
Public title	Improvement of the glycolipid metabolism during perisurgical period-Influence of preoperative starvation
Acronym	The glycolipid metabolism during perisurgical period
Scientific Title	Improvement of the glycolipid metabolism during perisurgical period-Influence of preoperative starvation
Scientific Title:Acronym	The glycolipid metabolism during perisurgical period
Region	Japan

Condition
Condition	oral surgery disease
Classification by specialty	Anesthesiology Oral surgery Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	During the perioperative periods in the infants, children and adults, the standard preoperative fasting is performed. Then, the body components(total body water, protein mass and muscle mass, glycogen and body fat content, etc.) are measured using Bioelectrial Impedance Analysis(BIA) method, as well as serum metabolic parameters (ketone bodies, blood glucose, free fatty acid, retinol binding protein, leptin, etc.). The difference of preoperative fasting to glycolipid metabolism in each age group will be clarified.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase

Assessment
Primary outcomes	The serum indicators of metabolism (blood ketone bodies, blood glucose, free fatty acid, retinol binding protein, leptin, etc.) during perisurgical periods are compared among several age groups.
Key secondary outcomes	The body component values (intra- and extra cellular water content, resting metabolic rate, protein, glycogen content, muscle mass and fat mass, etc.) during perisurgical periods are compared among several age groups.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification	YES
Dynamic allocation
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Food
Interventions/Control_1	Intervention period: 2 days (from the preoperative day to the operative day) Frequency of intervention: 1 time Contents of intervention: preoperative fluid intake with carbohydrate in adults. (In children, investigation of change of metabolism following preoperative fluid intake with carbohydrate as the other study.)
Interventions/Control_2	Intervention period: 2 days (from the preoperative day to the operative day) Frequency of intervention: 1 time Contents of intervention: preoperative fluid intake without carbohydrate in adults. (In children, investigation of change of metabolism following preoperative fluid intake with carbohydrate as the other study.)
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	1 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with oral surgery disease
Key exclusion criteria	Generally compromised patients with metabolic disease or patients having drugs affecting metabolism
Target sample size	34

Research contact person
Name of lead principal investigator	1st name Yoshinari Middle name Last name Morimoto
Organization	Graduate School of Dentistry, Kanagawa Dental University
Division name	Department of Critical Care Medicine and Dentistry
Zip code	2388580
Address	82, Inaoka-cho, Yokosuka, Kanagawa, 238-8580, Japan
TEL	046-822-8842
Email	morimoto@kdu.ac.jp

Public contact
Name of contact person	1st name Yoshinari Middle name Last name Morimoto
Organization	Graduate School of Dentistry, Kanagawa Dental University
Division name	Department of Critical Care Medicine and Dentistry
Zip code	2388580
Address	82, Inaoka-cho, Yokosuka, Kanagawa, 238-8580, Japan
TEL	046-822-8842
Homepage URL
Email	morimoto@kdu.ac.jp

Sponsor
Institute	Department of Critical Care Medicine and Dentistry, Graduate School of Dentistry, Kanagawa Dental University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science(JSPS)
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Graduate School of Dentistry, Kanagawa Dental University
Address	82, Inaoka-cho, Yokosuka, Kanagawa, 238-8580, Japan
Tel	046-822-8751
Email	kinugawa@kdu.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	25463133
Org. issuing International ID_1	Japan Society for the Promotion of Science(JSPS)
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 05 Month 01 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	No longer recruiting
Date of protocol fixation	2016 Year 04 Month 08 Day
Date of IRB	2016 Year 05 Month 09 Day
Anticipated trial start date	2016 Year 05 Month 09 Day
Last follow-up date	2018 Year 12 Month 01 Day
Date of closure to data entry	2018 Year 12 Month 01 Day
Date trial data considered complete	2018 Year 12 Month 01 Day
Date analysis concluded	2018 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date	2016 Year 04 Month 18 Day
Last modified on	2019 Year 10 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025267