Diabetes drug metformin may sharpen aging brains through gut bacteria
NCT ID NCT04841668
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether metformin, a standard diabetes medicine, can improve thinking and memory in older adults with type 2 diabetes by altering their gut bacteria. Fifty participants aged 55 to 80 will be followed for a year, with half taking metformin for six months. Researchers will test cognitive skills, monitor blood sugar, and analyze stool samples to find links between gut microbes and brain function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Metformin
- What this could lead to
- If successful, this could reveal how metformin improves cognition by changing gut bacteria, pointing toward new treatments for age-related mental decline.
- What could go wrong
- This is a small pilot study with only 50 participants, so results may not apply widely. It also cannot prove cause and effect, only associations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
50 people
The number who actually took part.
- Started
-
Apr 2021
- Finished
-
Dec 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Group A Study population Adult patients (≥ 65 years of age) recently diagnosed with T2DM according to the WHO and who have not been treated with metformin. Group B Study population Adult patients (≥ 65 years of age) diagnosed with long-term T2DM according to the WHO classification, regardless of whether they take metformin or other treatment.
- Ages
-
65 to 80 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Group A Inclusion Criteria: 1. Age between 55 and 80 years. 2. Patients with recently diagnosed T2DM (last 6 months), according to the WHO classification. 3. Patients in whom written informed consent has been obtained for participation in the study. Exclusion Criteria: 1. HbA1c ≥ 9% 2. Metformin treatment in the past 6 months 3. Creatinine greater than 1.2 and glomerular filtration rate less than 40 4. Serious systemic disease not related to obesity, including any type of cancer, severe kidney disease or liver disease, and known type 1 diabetes. 5. Systemic diseases with intrinsic inflammatory activity such as rheumatoid arthritis, Crohn's disease, asthma, or chronic infection (e.g., HIV, active tuberculosis) or any type of infectious disease. 6. Current treatment for malignant neoplasia, other than basal cell or squamous cell skin cancer. 7. Class III or IV heart disease, known ischemic cardiovascular disease 8. Kidney failure, history of kidney transplant, or current dialysis treatment 9. Serum liver enzymes (GOT, GPT) above twice the upper limit of normal. Obvious signs or symptoms of liver disease, acute or chronic hepatitis. 10. Chronic constipation (stool habit ≥ 7 days) 11. Pregnancy or breastfeeding 12. Treatments that affect glucose metabolism or the intestinal microbiota with biguanides, sulfonylurea secretagogues or non-sulfonylurea secretagogues, insulin sensitizers, insulin, thiazolidinediones, alpha glucosidase inhibitors, incretin mimetics, Dipeptidyl peptidase IV inhibitors, use of cathartics. 13. Chronic anti-inflammatory treatment with steroidal drugs (during the previous 3 months). 14. Symptoms and / or clinical signs of infection in the previous month. 15. Antibiotic, antifungal or antiviral treatment active in the previous 3 months. 16. Treatment with glucocorticoids chronic or during the 2 months prior to inclusion in the study. 17. Treatment with a weight loss product during the previous two months 18. Immunosuppressant treatment. 19. Excessive alcohol consumption (alcohol intake greater than 40 g per day (women) or 80 g / day (men)) either acute or chronic, or drug use. History of drug or alcohol abuse. 20. Patients with severe eating disorders 21. History of alterations in iron balance (known chronic hemoglobinopathies or anemia, genetic hemochromatosis, hemosiderosis from any cause, atransferrinemia, paroxysmal nocturnal hemoglobinuria). 22. Important psychiatric history. 23. Participation in any other study. 24. People whose freedom is under legal or administrative requirement. Group B Inclusion Criteria: 1. Age between 65 and 80 years. 2. Patients with long-term T2DM according to the WHO classification 3. Patients in whom written informed consent has been obtained for participation in the study. Exclusion Criteria: 1. HbA1c ≥ 9% 2. Creatinine greater than 1.2 and glomerular filtration rate less than 40 3. Serious systemic disease not related to obesity, including any type of cancer, severe kidney disease or liver disease, and known type 1 diabetes. 4. Systemic diseases with intrinsic inflammatory activity such as rheumatoid arthritis, Crohn's disease, asthma, or chronic infection (e.g., HIV, active tuberculosis) or any type of infectious disease. 5. Current treatment for malignant neoplasia, other than basal cell or squamous cell skin cancer. 6. Class III or IV heart disease, known ischemic cardiovascular disease. 7. Kidney failure, history of kidney transplant, or current dialysis treatment 8. Serum liver enzymes (GOT, GPT) above twice the upper limit of normal. Obvious signs or symptoms of liver disease, acute or chronic hepatitis. 9. Chronic constipation (stool habit ≥ 7 days) 10. Pregnancy or breastfeeding 11. Chronic anti-inflammatory treatment with steroidal drugs (during the previous 3 months). 12. Symptoms and / or clinical signs of infection in the previous month. 13. Antibiotic, antifungal or antiviral treatment active in the previous 3 months. 14. Treatment with glucocorticoids chronic or during the 2 months prior to inclusion in the study. 15. Treatment with a weight loss product during the previous two months. 16. Immunosuppressant treatment. 17. Excessive alcohol consumption (alcohol intake greater than 40 g per day (women) or 80 g / day (men)) either acute or chronic, or drug use. History of drug or alcohol abuse. 18. Patients with severe eating disorders 19. History of alterations in iron balance (known chronic hemoglobinopathies or anemia, genetic hemochromatosis, hemosiderosis from any cause, atransferrinemia, paroxysmal nocturnal hemoglobinuria). 20. Important psychiatric history. 21. Participation in any other study. 22. People whose freedom is under legal or administrative requirement.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Institut d'Investigació Biomèdica de Girona (IDIBGI)
Girona, Girona, 17007, Spain
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