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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.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