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Metformin and Immune Exhaustion in type 2 diabetes; Randomized Control Trial

Metformin and Immune Exhaustion in type 2 diabetes; Randomized Control Trial - Metformin and Immune Exhaustion in type 2 diabetes; Randomized Control Trial (METRO study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000018637
Enrollment
30
Registered
2015-08-11
Start date
2015-08-08
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

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 1

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Cytokine levels of IL-2, TNFalpha, IFNgamma in CD8 T cells.

Secondary

MeasureTime frame
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-).

Countries

Japan

Contacts

Public ContactJun Wada

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

junwada@okayama-u.ac.jp0862357232

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026