UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018637
Receipt number 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 2022/02/04 13:35:46

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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 or person

Institute

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

Institute

Department

Personal name



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

Completed

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

2018 Year 07 Month 30 Day

Date trial data considered complete

2018 Year 07 Month 30 Day

Date analysis concluded

2020 Year 07 Month 30 Day


Other

Other related information



Management information

Registered date

2015 Year 08 Month 11 Day

Last modified on

2022 Year 02 Month 04 Day



Link to view the page

Value
https://center6.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