UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014337 |
|---|---|
| Receipt number | R000016204 |
| Scientific Title | Study about the efficacy of metformin to immune function in healthy volunteers. |
| Date of disclosure of the study information | 2014/06/23 |
| Last modified on | 2019/05/03 22:04:16 |
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Basic information
Public title
Study about the efficacy of metformin to immune function in healthy volunteers.
Acronym
Study about the efficacy of metformin to immune function in healthy volunteers.
Scientific Title
Study about the efficacy of metformin to immune function in healthy volunteers.
Scientific Title:Acronym
Study about the efficacy of metformin to immune function in healthy volunteers.
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To examine the effect of metformin on T cells in vivo by administering metformin to healthy volunteers without malignancy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ability to produce cytokines (IL-2, TNF alpha, IFN gamma) and differentiation (memory, helper etc.) in peripheral blood T cells.
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Administering metformin of 500 mg after each meal everyday for two weeks.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Subjects who received a full explanation of the study and gave a written informed consent.
2. Subjects who weigh 50 to 80 kg and whose BMI is 18.5 or higher and less than 25.
3. Subjects who can complain abnormal and subjective symptoms if they suffer from them during the study.
Key exclusion criteria
1. Subjects who have symptoms which are judged to require follow-up or treatment.
2. Subjects who have previous medical history of hepatic disease, renal disease, cardiovascular disease, endocrine disease, gastrointestinal disease, respiratory disease, blood disorders and malignancy.
3. Subjects who have previous medical history of lactic acidosis.
4. Subjects who are allergic to medicines.
5. Subjects who need to take other medicines from 7 days before the study to the end of it.
6. Subjects who have drinking habit.
7. Subjects who drink caffeine-containing beverage in daily average of 1.8 L or more (coffee, tea, green tea, cola, health drink, etc.)
8. Subjects who smoke 2 packs or more in daily average.
9. Subjects who have been enrolled in the other clinical trials within last 4 months before the administration of metformin and administered any investigational new drugs.
10. Subjects who have made a blood donation prior to the administration of metformin.
11. Subjects who have been shown any problems at health examination.
12. Pregnant wouman
13. Other subjects who are judged to be ineligible in this trial by the investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Toyooka |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Clinical Genomic Medicine
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
TEL
086-235-7436
toyooka@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mototsugu Watanabe |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of General Thoracic Surgery and Breast and Endocrinological Surgery
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
TEL
086-235-7265
Homepage URL
mowatanabe@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
岡山大学病院（岡山県）
Okayama University Hospital（Okayama）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 23 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 21 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 21 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 21 | Day |
Last modified on
| 2019 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016204
