UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031993 |
|---|---|
| Receipt number | 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 09:37:56 |
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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
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
info@sdtc.jp
Sponsor or person
Institute
Sapporo diabetes, thyroid clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036519
