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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name