UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016800 |
|---|---|
| Receipt number | R000019371 |
| Scientific Title | Investigation into safety of preoperative oral intake of carbohydrate rich beverage in diabetic patients. Part2 |
| Date of disclosure of the study information | 2015/03/31 |
| Last modified on | 2018/03/18 12:21:50 |
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Basic information
Public title
Investigation into safety of preoperative oral intake of carbohydrate rich beverage in diabetic patients. Part2
Acronym
Preoperative oral intake of carbohydrate rich beverage in diabetic patients. Pert2
Scientific Title
Investigation into safety of preoperative oral intake of carbohydrate rich beverage in diabetic patients. Part2
Scientific Title:Acronym
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
| 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
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
motoi_sasuga@tmhp.jp
Sponsor or person
Institute
Department of anesthesiology, Tokyo Metropolitan Tama Medical Center
Institute
Department
Personal name
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
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 |
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
| 2014 | Year | 01 | Month | 18 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019371
