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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012759
Receipt No. R000014908
Scientific Title The influence of oral carbohydrate loading on glucose and lipid metabolism in type 2 diabetes patients
Date of disclosure of the study information 2014/01/06
Last modified on 2018/06/11

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Basic information
Public title The influence of oral carbohydrate loading on glucose and lipid metabolism in type 2 diabetes patients
Acronym The influence of oral carbohydrate loading on glucose and lipid metabolism in type 2 diabetes patients
Scientific Title The influence of oral carbohydrate loading on glucose and lipid metabolism in type 2 diabetes patients
Scientific Title:Acronym The influence of oral carbohydrate loading on glucose and lipid metabolism in type 2 diabetes patients
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the influence of oral carbohydrate loading adopted for preoperative oral rehydration therapy on glucose and lipid metabolism in type 2 diabetes patients.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary outcome is blood glucose level. Especially, it will compare the fluctuation of blood glucose level loading oral carbohydrate beverage with its loading water.
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 10 inpatients who are treated with insulin for type 2 diabetes or 5 inpatients without diabetes.
All patients will drink water (1st day), OS-1 (2nd day) and Arginaid Water (3rd day).
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

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Inpatients treated with insulin for type 2 diabetes whom glycemic control are stable (fasted blood glucose level is less than 150 mg/dL, and postpradial blood glucose level is less than 250 mg/dL).
Key exclusion criteria Type 1 diabetes
Patients treated with steroid
Patients whom fasted blood glucose level is more than 150 mg/dL
Patients whom postpradial blood glucose level is more than 250 mg/dL
Patients who have severe autonomic failure
Patients who were admitted with diabetic ketoacidosis, hyperosmolar hyperglycemic nonketotic coma or lactic acidosis
Patients treated with continuous injection
Patients who have appetite loss or are unable to eat orally
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiichi Araki
Organization Faculty of Life Sciences, Kumamoto University
Division name Department of Metabolic Medicine
Zip code
Address 1-1-1 Honjo, Kumamoto, Japan
TEL 096-373-5169
Email earaki@gpo.kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junji Kawashima
Organization Faculty of Life Sciences, Kumamoto University
Division name Department of Metabolic Medicine
Zip code
Address 1-1-1 Honjo, Kumamoto, Japan
TEL 096-373-5169
Homepage URL
Email junjikawa@mac.com

Sponsor
Institute Department of Metabolic Medicine, Kumamoto University Hospital
Institute
Department

Funding Source
Organization Otsuka Phamaceutical Factory, Inc
Organization
Division
Category of Funding Organization Profit organization
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 熊本大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 06 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
2013 Year 12 Month 25 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 10 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
2014 Year 01 Month 06 Day
Last modified on
2018 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014908

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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