UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021958 |
|---|---|
| Receipt number | R000025267 |
| Scientific Title | Improvement of the glycolipid metabolism during perisurgical period-Influence of preoperative starvation |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2019/10/21 13:11:11 |
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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
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
morimoto@kdu.ac.jp
Sponsor or person
Institute
Department of Critical Care Medicine and Dentistry, Graduate School of Dentistry, Kanagawa Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025267
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