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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011644
Receipt No. R000013614
Scientific Title Improvement of the glycolipid metabolism in infants during perisurgical period-1. Influence of preoperative starvation
Date of disclosure of the study information 2013/09/17
Last modified on 2019/03/12

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Basic information
Public title Improvement of the glycolipid metabolism in infants during perisurgical period-1. Influence of preoperative starvation
Acronym The glycolipid metabolism in infants during perisurgical period
Scientific Title Improvement of the glycolipid metabolism in infants during perisurgical period-1. Influence of preoperative starvation
Scientific Title:Acronym The glycolipid metabolism in infants during perisurgical period
Region
Japan

Condition
Condition Cleft lip and palate
Classification by specialty
Anesthesiology Oral surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Before general anesthesia of the infants, the standard preoperative fasting is performed. Then, the body components (total body water, protein mass and muscle mass, glycogen and body fat content, etc.) in infants are mesured using Bioelectrical Impedance Analysis to (BIA) method, as well as serum metabolic parameters (ketone body, blood glucose, free fatty acid, retinol binding protein, leptin, etc.). The influence of standard preoperative fasting to glycolipid metabolism in each age group is clarified.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Others
Developmental phase

Assessment
Primary outcomes Comparison of body component values (intra-and extra-cellular water content, resting metabolic rate, protein, glycogen content, muscle mass and fat mass, etc.), measured between the day before general anesthesia and those immediately after anesthesia induction.
Key secondary outcomes Blood ketone bodies, blood glucose, free fatty acid, retinol binding protein, leptin, etc. as serum indicators of metabolism

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 Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
2 months-old <=
Age-upper limit
24 months-old >=
Gender Male and Female
Key inclusion criteria Cleft lip and palate infants
Key exclusion criteria Generally compromised infants
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinari
Organization Graduate School of Dentistry, kanagawa Dental University
Division name Department of Critical Care Medicine and Dentistry
Zip code
Address 82, Inaoka-cho, Yokosuka, Kanagawa, 238-8580, Japan
TEL 0468228893
Email morimoto@kdu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Morimoto
Organization Kanagawa Dental University
Division name Department of Critical Care Medicine and Dentistry
Zip code
Address 82, Inaoka-cho, Yokosuka, kanagawa, 238-8580, Japan
TEL 0468228893
Homepage URL
Email morimoto@kdu.ac.jp

Sponsor
Institute Department of Dental Anesthesiology, Graduate School of Dentistry, Osaka University
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 Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 09 Month 17 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
2013 Year 07 Month 29 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 20 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The body component values (intra-and extra-cellular water content, resting metabolic rate, protein, glycogen content, muscle mass and fat mass, etc.) and serum metabolic parameters (ketone bodies, blood glucose, free fatty acid, retinol binding protein, leptin, etc.) measured between the day before general anesthesia and those immediately after anesthesia induction are compared.


Management information
Registered date
2013 Year 09 Month 03 Day
Last modified on
2019 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013614


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