UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009537 |
|---|---|
| Receipt number | R000010484 |
| Scientific Title | Investigation for the relationship between insulin resistance and alcohol intake. |
| Date of disclosure of the study information | 2012/12/14 |
| Last modified on | 2015/06/15 13:16:39 |
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Basic information
Public title
Investigation for the relationship between insulin resistance and alcohol intake.
Acronym
The relationship between alcohol intake and insulin resistance.
Scientific Title
Investigation for the relationship between insulin resistance and alcohol intake.
Scientific Title:Acronym
The relationship between alcohol intake and insulin resistance.
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of alcohol comsumption on insulin resistance in human.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Insulin sensitivity in liver and muscle
Intracelluler lipid in liver and muscle
Glucose metabolism before and after oral glucose load
Key secondary outcomes
body weight
body fat
Visceral fat volume
subcutaneous fat volume
Liver function test
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 | Behavior,custom |
Interventions/Control_1
non alcohol consumption for one week
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
| 25 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male
Key inclusion criteria
1)Healty men who are more than 25 year-old .
2)Subjects whose body mass index are less than 25.
3)The subjects who drink alcohol in most of day.
4)The subjects whose fasting blood glucose are more than 95mg/dl.
5)The subjects who are able to read and understand the written informed consent.
Key exclusion criteria
1)The subjects who were suffered from serious disease.
2)The subjects who are treated with/without medication.
3)The subjects who have a history of allergy to local anesthetics.
4)The subjects who suspected of alcoholism.
5)The subjects who drink alcohol more than 110g/day .
6)The subjects who are not applicable to this study judged by the medical doctor.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshifumi Tamura |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Metabolisma and Endocrinology
Zip code
Address
2-1-1 Hongo Bunkyo-ku Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Metabolism and Endocrinology
Zip code
Address
2-1-1 Hongo Bunkyo-ku Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
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
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 14 | 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
| 2012 | Year | 01 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | 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
| 2012 | Year | 12 | Month | 13 | Day |
Last modified on
| 2015 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010484
