UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010914 |
|---|---|
| Receipt number | R000012772 |
| Scientific Title | The effects of intraoperative administration of glucose on protein and fatty catabolism in diabetic patients |
| Date of disclosure of the study information | 2013/06/10 |
| Last modified on | 2015/04/20 18:16:52 |
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Basic information
Public title
The effects of intraoperative administration of glucose on protein and fatty catabolism in diabetic patients
Acronym
The impact of intraoperative administration of glucose in diabetic patients
Scientific Title
The effects of intraoperative administration of glucose on protein and fatty catabolism in diabetic patients
Scientific Title:Acronym
The impact of intraoperative administration of glucose in diabetic patients
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate whether intraoperative administration of glucose inhibits catabolism in diabetic patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diabetic patients undergoing general anesthesia will be divided into two groups whether or not glucose is administered intraperatively. The endogenous substances related to glucose metabolism will be measured during surgery.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
glucose
duration: during operation
dose: 1.5mg/kg/min
blood collection:the start, 6 hours after start, and the end of operation
15ml each
Interventions/Control_2
no glucose
duration: during operation
dose: 0
blood collection:the start, 6 hours after start, and the end of operation
15ml each
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
diabetic patients undergoing general anesthesia
Key exclusion criteria
N/A
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Maiko Hasegawa-Moriyama |
Organization
Kagoshima University Hospital
Division name
Anesthesiology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, Japan
TEL
099-275-5430
hase-mai@m3.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maiko Hasegawa |
Organization
Kagoshima University Hospital
Division name
Anesthesiology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima-shi
TEL
0992755430
Homepage URL
hase-mai@m3.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kagoshima University
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 06 | Month | 10 | 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 | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 09 | Day |
Last modified on
| 2015 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012772
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
