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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024983
Receipt No. R000028750
Scientific Title Evaluation of blood sugar level after preoperative oral rehydration by the carbohydrate-containing fluids for diabetes patients used with current oral hypoglycemic agents
Date of disclosure of the study information 2016/11/29
Last modified on 2016/11/24

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Basic information
Public title Evaluation of blood sugar level after preoperative oral rehydration by the carbohydrate-containing fluids for diabetes patients used with current oral hypoglycemic agents
Acronym Preoperative ORT for DM patients used with current oral hypoglycemic agents
Scientific Title Evaluation of blood sugar level after preoperative oral rehydration by the carbohydrate-containing fluids for diabetes patients used with current oral hypoglycemic agents
Scientific Title:Acronym Preoperative ORT for DM patients used with current oral hypoglycemic agents
Region
Japan

Condition
Condition diabetes mellitus
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the blood sugar level of diabetes patients undergoing elective surgery after oral rehydration by the carbohydrate-containing fluids when the patients take BG, TZD derivatives, alpha-GI or DPP-4 inhibitor on the morning of surgical day if the patients have been taken them currently.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Whether blood sugar levels at arriving to the operating room significant decrease compared with when diabetes patients have been taken no current oral hypoglycemic agents on the morning of surgical day.

Key secondary outcomes no symptoms of hypoglycemia during awating period

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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
Medicine
Interventions/Control_1 If diabetes patients undergoing elective surgery have been taken BG, TZD derivatives, alpha-GI or DPP-4 inhibitor currently, the patients take these four kinds of current oral hypoglycemic agents on the morning of surgical day.
Interventions/Control_2 Diabetes patients undergoing elective surgery take no current oral hypoglycemic agents on the morning of surgical day.
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 diabetes patients undergoing elective surgery treated with oral hypoglycemic drugs currently
Key exclusion criteria 1)insulin-treated patients
2)HbA1c>=8.0
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Susumu Kasama
Organization Nagano Prefectural Rehabilitation Center
Division name Department of anesthesiology
Zip code
Address 618-1 Shimokomazawa, Nagano City, Nagano, Japan
TEL 026-296-3953
Email ksmassmu@plum.plala.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Susumu Kasama
Organization Nagano Prefectural Rehabilitation Center
Division name Department of anesthesiology
Zip code
Address 618-1 Shimokomazawa, Nagano City, Nagano, Japan
TEL 026-296-3953
Homepage URL
Email ksmassmu@plum.plala.or.jp

Sponsor
Institute Nagano Prefectural Rehabilitation 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)

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 11 Month 29 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 Enrolling by invitation
Date of protocol fixation
2014 Year 07 Month 14 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 17 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 11 Month 24 Day
Last modified on
2016 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028750

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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