UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation into safety of preoperative oral intake of carbohydrate rich beverage in diabetic patients. Part2
Title of the study (Brief title)	Preoperative oral intake of carbohydrate rich beverage in diabetic patients. Pert2
Region	Japan

Condition
Condition	Diabetic patients undergoing surgery with general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	They say preoperative oral intake of carbohydrate rich beverage improves preoperative thirst, hunger and insulin resistance. But in diabetic patients hyperglycemia induced by oral intake of carbohydrate rich beverage was concerned. And so we examined the safety of preoperative oral intake of carbohydrate rich beverage in diabetic patients.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Blood glucose level after induction of anesthesia.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Group A: Type 2 diabetes patients were not permitted to take solid food from 2100 hours the day before surgery, permitted to drink clear fluid and encouraged to drink carbohydrate rich beverage (Arginaid Water) until 700 hours the day of surgery. After induction of general anesthesia, radial arterial catheter was inserted and blood gas analysis was done. From September 2012 to April 2014, Data were collected in the study registered UMIN000011266.
Interventions/Control_2	Group C: Type 2 diabetes patients were not permitted to take solid food from 2100 hours the day before surgery, permitted to drink clear fluid. After induction of general anesthesia, radial arterial catheter was inserted and blood gas analysis was done. From January 2011 to September 2012, data were collected in medical records retrospectively.
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with type 2 diabetes mellitus who underwent surgery with general anesthesia entering the operating room at 845 hours.
Key exclusion criteria	Type 1 diabetes mellitus Final stage of a terminal illness Untreated diabetes Uncontrolled diabetes Unconsciousness Emergency surgeries Cardiac surgeries
Target sample size	54

Research contact person
Name of lead principal investigator	Motoi Sasuga
Organization	Tokyo Metropolitan Tama Medical Center
Division name	Department of anesthesiology
Address	2-8-29 Musashidai, Fuchu, Tokyo 183-8524, Japan
TEL	042-323-5111
Email	motoi_sasuga@tmhp.jp

Public contact
Name of contact person	Motoi Sasuga
Organization	Tokyo Metropolitan Tama Medical Center
Division name	Department of anesthesiology
Address	2-8-29 Musashidai, Fuchu, Tokyo 183-8524, Japan
TEL	042-323-5111
Homepage URL
Email	motoi_sasuga@tmhp.jp

Sponsor
Institute	Department of anesthesiology, Tokyo Metropolitan Tama Medical Center
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 03 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 18 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 03 Month 14 Day
Last modified on	2018 Year 03 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019371