UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The influence of oral carbohydrate loading on glucose and lipid metabolism in type 2 diabetes patients
Title of the study (Brief title)	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	Eiichi Araki
Organization	Faculty of Life Sciences, Kumamoto University
Division name	Department of Metabolic Medicine
Address	1-1-1 Honjo, Kumamoto, Japan
TEL	096-373-5169
Email	earaki@gpo.kumamoto-u.ac.jp

Public contact
Name of contact person	Junji Kawashima
Organization	Faculty of Life Sciences, Kumamoto University
Division name	Department of Metabolic Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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