UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012759 |
|---|---|
| Receipt number | 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 10:59:22 |
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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
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
junjikawa@mac.com
Sponsor or person
Institute
Department of Metabolic Medicine, Kumamoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014908
