UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011644 |
|---|---|
| Receipt number | 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 | 2023/06/16 17:29:33 |
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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
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
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 | MORIMOTO |
| Middle name | |
| Last name | Yoshinari |
Organization
Graduate School of Dentistry, kanagawa Dental University
Division name
Department of Critical Care Medicine and Dentistry
Zip code
238-8580
Address
82, Inaoka-cho, Yokosuka, Kanagawa, 238-8580, Japan
TEL
0468228893
morimoto@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinari |
| Middle name | |
| Last name | Morimoto |
Organization
Kanagawa Dental University
Division name
Department of Critical Care Medicine and Dentistry
Zip code
238-8580
Address
82, Inaoka-cho, Yokosuka, kanagawa, 238-8580, Japan
TEL
0468228893
Homepage URL
morimoto@kdu.ac.jp
Sponsor or person
Institute
Department of Dental Anesthesiology, Graduate School of Dentistry, Osaka University
Institute
Department
Personal name
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
Osaka University
Address
1-8, Yamadaoka, Suita, Osaka, Japan
Tel
09059605429
morimoto@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
| 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
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 30 | Day |
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
| 2023 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013614
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
