UMIN-CTR Clinical Trial

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
Last 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
Email	toyooka@md.okayama-u.ac.jp

Public contact
1st 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
Email	mowatanabe@s.okayama-u.ac.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016204