NCT04841668Completed
Gut-Brain-axis: Targets for Improvement of Cognition in the Elderly
Source: ClinicalTrials.gov · Last updated 31 Mar 2026
Brief summary (registry, in English)
Cognitive disorders increase with age and in the presence of metabolic diseases such as Type 2 Diabetes Mellitus (T2DM). In addition, digestive disorders, changes in dietary pattern and decreased activity negatively influence the microbiome. The hypothesis is that pharmacological intervention with metformin will modify the composition of the gut microbiota and cognition. The study has a pilot longitudinal design, where each patient with T2DM will be followed for one year. Two groups will be recruited: 1. Group A: The aim will be to evaluate the associations between glucose (measured by continuous glucose monitoring (CGM)), cognitive function (by means of cognitive tests and magnetic resonance imaging (MRI)), physical activity (recorded by activity and sleep tracker devicer), metformin, diet (evaluated by nutritional survey) and composition of the microbiota (evaluated by metagenomics), during 12 months (6 months without metformin and 6 months with metformin treatment). 2. Group B: The aim will be to evaluate the associations between glucose, diet (evaluated by nutritional survey), cognitive function (by means of cognitive tests), physical activity (measured by activity and sleep tracker device), the treatment and composition of the microbiota (evaluated by metagenomics), during 12 months.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 50 (actual)
- First submitted
- 6 Apr 2021
- Start date
- 10 Apr 2021
- Primary completion date
- 3 Dec 2024
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Diseases
- Type 2 diabetes
- NCT number
- NCT04841668
What you commit to
- Study type: Observational
- Participants enrolled: 50
- From 10 Apr 2021 to the primary completion date, 3 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Chronic anti-inflammatory treatment with steroidal drugs (during the previous 3 months).
- Symptoms and / or clinical signs of infection in the previous month.
- Antibiotic, antifungal or antiviral treatment active in the previous 3 months.
- Treatment with glucocorticoids chronic or during the 2 months prior to inclusion in the study.
- Treatment with a weight loss product during the previous two months
- Chronic anti-inflammatory treatment with steroidal drugs (during the previous 3 months).
- Symptoms and / or clinical signs of infection in the previous month.
- Antibiotic, antifungal or antiviral treatment active in the previous 3 months.
- Treatment with glucocorticoids chronic or during the 2 months prior to inclusion in the study.
- Treatment with a weight loss product during the previous two months.
Other illness
- Serious systemic disease not related to obesity, including any type of cancer, severe kidney disease or liver disease, and known type 1 diabetes.
- 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.
- Current treatment for malignant neoplasia, other than basal cell or squamous cell skin cancer.
- Class III or IV heart disease, known ischemic cardiovascular disease
- Kidney failure, history of kidney transplant, or current dialysis treatment
- 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.
- Patients with severe eating disorders
- History of alterations in iron balance (known chronic hemoglobinopathies or anemia, genetic hemochromatosis, hemosiderosis from any cause, atransferrinemia, paroxysmal nocturnal hemoglobinuria).
- Important psychiatric history.
- Serious systemic disease not related to obesity, including any type of cancer, severe kidney disease or liver disease, and known type 1 diabetes.
- 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.
- Current treatment for malignant neoplasia, other than basal cell or squamous cell skin cancer.
- Class III or IV heart disease, known ischemic cardiovascular disease.
- Kidney failure, history of kidney transplant, or current dialysis treatment
- 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.
- Patients with severe eating disorders
- History of alterations in iron balance (known chronic hemoglobinopathies or anemia, genetic hemochromatosis, hemosiderosis from any cause, atransferrinemia, paroxysmal nocturnal hemoglobinuria).
- Important psychiatric history.
Lab values
- HbA1c ≥ 9%
- Creatinine greater than 1.2 and glomerular filtration rate less than 40
- Serum liver enzymes (GOT, GPT) above twice the upper limit of normal. Obvious signs or symptoms of liver disease, acute or chronic hepatitis.
- 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.
- HbA1c ≥ 9%
- Creatinine greater than 1.2 and glomerular filtration rate less than 40
- Serum liver enzymes (GOT, GPT) above twice the upper limit of normal. Obvious signs or symptoms of liver disease, acute or chronic hepatitis.
Other
- Metformin treatment in the past 6 months
- Chronic constipation (stool habit ≥ 7 days)
- Pregnancy or breastfeeding
- Immunosuppressant treatment.
- Participation in any other study.
- People whose freedom is under legal or administrative requirement.
- Group B
- Chronic constipation (stool habit ≥ 7 days)
- Pregnancy or breastfeeding
- Immunosuppressant treatment.
- Participation in any other study.
- People whose freedom is under legal or administrative requirement.
Who the study is looking for
- Age between 55 and 80 years.
- Patients with recently diagnosed T2DM (last 6 months), according to the WHO classification.
- Patients in whom written informed consent has been obtained for participation in the study.
- Age between 65 and 80 years.
- Patients with long-term T2DM according to the WHO classification
- Patients in whom written informed consent has been obtained for participation in the study.
Criteria the registry did not label
- Group A
Age in the registry: 65 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut d'Investigació Biomèdica de Girona (IDIBGI) Coordinator of this site? Confirm its status | Girona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.