UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020884 |
|---|---|
| Receipt number | R000024097 |
| Scientific Title | Effects of perioperative glucose management on catabolism and postoperative insulin resistance |
| Date of disclosure of the study information | 2016/02/05 |
| Last modified on | 2016/02/16 19:40:45 |
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Basic information
Public title
Effects of perioperative glucose management on catabolism and postoperative insulin resistance
Acronym
perioperative nutritional management
Scientific Title
Effects of perioperative glucose management on catabolism and postoperative insulin resistance
Scientific Title:Acronym
perioperative nutritional management
Region
| Japan |
Condition
Condition
Jaw deformity
Classification by specialty
| Anesthesiology | Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of intraoperative administration of low-dose glucose on catabolism and postoperative insulin resistance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
insulin resistance on the next morning of surgery
Key secondary outcomes
fat and protein catabolism during surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention group 1: the group receiving acetated Ringer solution with 1.5% glucose during surgery.
Interventions/Control_2
Intervention group 2: the group receiving acetated Ringer solution without glucose and continuous administration glucose at 0.08 g/kg/h during surgery.
Interventions/Control_3
Control group: the group receiving acetated Ringer solution without glucose during surgery.
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
adult patients undergoing elective axillofacial surgery
Key exclusion criteria
Patients with diabetes and/or obesity >body mass index (BMI) 25 kg/m^2
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Yokoyama |
Organization
kyushu university
Division name
dental anesthesiology
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
092-642-6480
yokoyama@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Hirokawa |
Organization
kyushu university
Division name
dental anesthesiology
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
092-642-6480
Homepage URL
hj8823@dent.kyushu-u.ac.jp
Sponsor or person
Institute
department of dental anesthesiology, kyushu university
Institute
Department
Personal name
Funding Source
Organization
Nikkiso Co, Ltd, (Tokyo, Japan)
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 02 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2011 | Year | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 04 | Day |
Last modified on
| 2016 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024097
