UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031993
Receipt No. R000036519
Scientific Title Study for the association between glycometabolism and alcohol metabolism in the glucose tolerance normal person.
Date of disclosure of the study information 2018/03/30
Last modified on 2019/09/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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/ctr_e/ctr_view.cgi?recptno=R000036519

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.