Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Diabetes drug metformin may sharpen aging brains through gut bacteria

NCT ID NCT04841668

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Type 2 diabetes mellitus are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.