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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018637
Receipt No. R000021524
Scientific Title Metformin and Immune Exhaustion in type 2 diabetes; Randomized Control Trial
Date of disclosure of the study information 2015/08/11
Last modified on 2020/08/17

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Basic information
Public title Metformin and Immune Exhaustion in type 2 diabetes; Randomized Control Trial
Acronym Metformin and Immune Exhaustion in type 2 diabetes; Randomized Control Trial (METRO study)
Scientific Title Metformin and Immune Exhaustion in type 2 diabetes; Randomized Control Trial
Scientific Title:Acronym Metformin and Immune Exhaustion in type 2 diabetes; Randomized Control Trial (METRO study)
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the status of immune-exhaustion of peripheral T cells in the patients with type 2 diabetes and investigate the influence of metformin on the status of immune-exhaustion. We also compare the the status of immune-exhaustion of peripheral T cells between the patients with type 2 diabetes and subjects with normal glucose tolerance.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cytokine levels of IL-2, TNFalpha, IFNgamma in CD8 T cells.
Key secondary outcomes Expression of CTLA-4, PD-1, Tim-3 on CD4 cells (TH1, TH2, regulatory T cells), Naive T cells (CCR7+ CD45RA+), effector memory T cells (CCR7LoCD45RA-), and central memory T cells (CCR7HiCD45RA-).

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Metformin group (additional drug therapies can be used in both groups). Metformin 500-1500mg/day will be administered for 2 months. If the patients are tolerable, the daily dose will be increased to 1500 mg/day.
Interventions/Control_2 Non-metformin group (additional drug therapies can be used in both groups)
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1. The patients with type 2 diabetes, who understand the purpose, methods and side effect of metformin and give written informed conscent.
2. The patients with type 2 diabetes, who claim the unwanted symptoms and signs.
3. The patients with type 2 diabetes, not less than 20 years old and not more than 75 years old.
4. The patients with type 2 diabetes, who do not receive metformin.
Key exclusion criteria 1. Lactic acidosis
2. Moderate renal dysfunction
3. Hemodialysis patients
4. Severe liver dysfunction
5. Shock, heart failure, cardiac infarction pulmonary embolism, respiratory failure, hypoxia
6. Alcohol intake
7. Dehydration, diarrhea with dehydration, vomiting
8. Severe ketosis, diabetic coma and precoma, tyep 1 diabetes
9. Severe infection, pre- and post-operation, severe trauma
10. Malnutrition, famine, panhypopituitarism and adrenal failure
11. Pregnancy
12. Allergic to biguanides
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Jun
Middle name
Last name Wada
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code 700-0914
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL 0862357232
Email junwada@okayama-u.ac.jp

Public contact
Name of contact person
1st name Jun
Middle name
Last name Wada
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code 700-0914
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL 0862357232
Homepage URL
Email junwada@okayama-u.ac.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences; Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Institute
Department

Funding Source
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences; Department of Nephrology, Rheumatology, Endocrinology and Metabolism
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 Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
Tel 086-235-6938
Email mae6605@adm.okayama-u.ac.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
2015 Year 08 Month 11 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 Enrolling by invitation
Date of protocol fixation
2015 Year 08 Month 08 Day
Date of IRB
2014 Year 12 Month 22 Day
Anticipated trial start date
2015 Year 08 Month 08 Day
Last follow-up date
2018 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 07 Month 05 Day

Other
Other related information

Management information
Registered date
2015 Year 08 Month 11 Day
Last modified on
2020 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021524

Research Plan
Registered date File name
2020/08/17 メトホルミン実施計画書0126(最終版).docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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