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Recruitment status Completed
Unique ID issued by UMIN UMIN000011266
Receipt No. R000013026
Scientific Title Investigation into safety of preoperative oral intake of carbohydrate rich beverage in diabetic patients
Date of disclosure of the study information 2013/08/31
Last modified on 2015/03/03

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Basic information
Public title Investigation into safety of preoperative oral intake of carbohydrate rich beverage in diabetic patients
Acronym Preoperative oral intake of carbohydrate rich beverage in diabetic patients
Scientific Title Investigation into safety of preoperative oral intake of carbohydrate rich beverage in diabetic patients
Scientific Title:Acronym Preoperative oral intake of carbohydrate rich beverage in diabetic patients
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 bicarbonate 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 and during surgery.
Key secondary outcomes Gastric volume and pH at the induction of anesthesia.
Relation between blood glucose level during anesthesia and HbA1c or preoperative blood glucose level

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
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 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motoi Sasuga
Organization Tokyo Metropolitan Tama Medical Center
Division name Department of anesthesiology
Zip code
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
1st name
Middle name
Last name Motoi Sasuga
Organization Tokyo Metropolitan Tama Medical Center
Division name Department of anesthesiology
Zip code
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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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 東京都立多摩総合医療センター

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 31 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
2012 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 20 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
2013 Year 07 Month 24 Day
Last modified on
2015 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013026


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