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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002710
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Dep. of Anesthesiology, School of Medicine, Showa Univ.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003253

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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