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
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
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
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
