UMIN-CTR Clinical Trial

Basic information
Public title	Study for the association between glycometabolism and alcohol metabolism in the glucose tolerance normal person.
Acronym	Study for the association between glycometabolism and alcohol metabolism.
Scientific Title	Study for the association between glycometabolism and alcohol metabolism in the glucose tolerance normal person.
Scientific Title:Acronym	Study for the association between glycometabolism and alcohol metabolism.
Region	Japan

Condition
Condition	Glucose tolerance normal person
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine an association between glycometabolism and alcohol metabolism in the glucose tolerance normal person.
Basic objectives2	Others
Basic objectives -Others	To examine the following. (1) Glucose tolerance after the 75g glucose intake. (2) Glucose tolerance after the 20g alcohol intake (3) Glucose tolerance and the alcohol metabolism after having taken in 20g alcohol and 75g glucose at the same time.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison of the blood glucose change in each endurance test
Key secondary outcomes	(1)Hypoglycemic level, presence or absence of hypoglycemic symptom (2)Blood alcohol level and loss time (3)Change of the FFA and triglyceride (4)Change of the insulin level (5)Stratified analysis by the subjects background

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	Sapporo soft 20% Trelan-G75
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	(1)subjects with written informed consent (2)subjects that glucose tolerance is normal (3)subjects with the alcohol consumption habit
Key exclusion criteria	(1)patients with severe hepatic dysfunction, renal dysfunction, heart failure (2)subjects of the diathesis that cannot drink, (3)subjects with a history of poor physical condition and hypersensitivity for alcohol (4)pregnancy (5)subjects with impaired glucose tolerance (6)subjects who drive on test day (7)subjects who are inadequate to enter this study due to the other reasons by physician's judgments
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name Takeuchi
Organization	Sapporo diabetes, thyroid clinic
Division name	Sapporo diabetes, thyroid clinic
Zip code	060-0807
Address	Nishi 2, Kita 7, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-707-1024
Email	jun_takeuchi@me.com

Public contact
Name of contact person	1st name Jun Middle name Last name Takeuchi
Organization	Sapporo diabetes, thyroid clinic
Division name	Sapporo diabetes, thyroid clinic
Zip code	060-0807
Address	Nishi 2, Kita 7, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-707-1024
Homepage URL
Email	info@sdtc.jp

Sponsor
Institute	Sapporo diabetes, thyroid clinic
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	Sapporo Medical Associations ERB
Address	19-1-1, Odorinishi, Chuo-ku Sapporo-shi, Hokkaido, 060-8581, Japan
Tel	011-611-4181
Email	chiken@spmed.or.jp

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	2018 Year 03 Month 30 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	2018 Year 03 Month 05 Day
Date of IRB	2018 Year 03 Month 16 Day
Anticipated trial start date	2018 Year 03 Month 16 Day
Last follow-up date	2018 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 30 Day
Last modified on	2019 Year 09 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036519