UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002710 |
|---|---|
| Receipt number | R000003253 |
| Scientific Title | The influence of glucose administration during surgery on the postoperative glucose metabolism in the patients undergoing elective gastrectomy |
| Date of disclosure of the study information | 2009/12/01 |
| Last modified on | 2013/06/05 20:20:12 |
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Basic information
Public title
The influence of glucose administration during surgery on the postoperative glucose metabolism in the patients undergoing elective gastrectomy
Acronym
The influence of glucose administration during surgery on the postoperative glucose metabolism
Scientific Title
The influence of glucose administration during surgery on the postoperative glucose metabolism in the patients undergoing elective gastrectomy
Scientific Title:Acronym
The influence of glucose administration during surgery on the postoperative glucose metabolism
Region
| Japan |
Condition
Condition
Malignant tumor of stomach
Classification by specialty
| Gastrointestinal surgery | Anesthesiology | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The influence of intraoperative glucose administration on the postoperative glucose metabolism is investigated in the elective-gastrectomy patients randomly assigned to the group administered the extracellular fluid replacement solution containing 1% glucose or the group administered such solution without glucose.
The primary endpoint is the postoperative glucose metabolism, evaluated by the HOMA-IR [(serum glucose level, mg/dL x serum insulin level, microL/mL)/405] that is a parameter of insulin resistance.
The secondary endpoints are intraoperative glucose tolerance (evaluated by the levels of serum glucose, insulin, and C-peptide), intraoperative fat metablism (evaluated by the levels of serum free fatty acid and ketone bodies), and intraoperative protein metabolism (evaluated by the level of urinary 3-methylhistidine).
Basic objectives2
Others
Basic objectives -Others
The influence of glucose administration during surgery on the postoperative glucose metabolism
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative glucose metabolism evaluated by the insulin resistance (HOMA-IR) calculated by the following equation:
HOMA-IR= serum glucose level (mg/dL) x serum insulin level (microU/mL )/405
The values are measured in early morning of the day following the surgery.
Key secondary outcomes
1. Intraoperative glucose tolerance (serum glucose, insulin, and C-peptide)
2. Intraoperative protein metabolism (urinary 3-methyhistidine)
3. Intraoperative fat metabolism (serum free fatty acid and ketone bodies)
The values are measured every 2 hours during the surgery.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
An extracellular fluid replacement solution containing 1% glucose is administered during surgery.
Interventions/Control_2
An extracellular fluid replacement solution without glucose is administered during surgery.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 20 years or older
2. Male patients or female patients
3. Patients in ASA category I to II
4. Patients who provide informed consent before registration
Key exclusion criteria
1. Patients with hypermagnesemia
2. Patients with hypothyroidism
3. Diabetic patients, patients with abnormal glucose tolerance, and the patients with such disease histories
4. Patients with severe heart diseases
5. Patients with severe kidney dysfunction
6. Patients with severe liver dysfunction
7. Others who are deemed unsuitable for inclusion in the study for any other reason based on the assessment by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Otsuka |
Organization
School of Medicine, Showa Univ.
Division name
Dep. of Anesthesiology
Zip code
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
School of Medicine, Showa Univ.
Division name
Dep. of Anesthesiology
Zip code
Address
TEL
03-3784-8575
Homepage URL
Sponsor or person
Institute
Dep. of Anesthesiology, School of Medicine, Showa Univ.
Institute
Department
Personal name
Funding Source
Organization
Dep. of Anesthesiology, School of Medicine, Showa Univ.
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
| 2009 | Year | 12 | 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
Completed
Date of protocol fixation
| 2009 | Year | 10 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 06 | Month | 20 | Day |
Date trial data considered complete
| 2012 | Year | 06 | Month | 20 | Day |
Date analysis concluded
| 2013 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 05 | Day |
Last modified on
| 2013 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003253
