Gut-Brain-axis: Targets for Improvement of Cognition in the Elderly
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
136 participants
Apr 10, 2021
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- Group A
- 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.
Exclusion Criteria47
- HbA1c ≥ 9%
- Metformin treatment in the past 6 months
- Creatinine greater than 1.2 and glomerular filtration rate less than 40
- 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
- Serum liver enzymes (GOT, GPT) above twice the upper limit of normal. Obvious signs or symptoms of liver disease, acute or chronic hepatitis.
- Chronic constipation (stool habit ≥ 7 days)
- Pregnancy or breastfeeding
- 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.
- 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
- Immunosuppressant 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.
- Participation in any other study.
- People whose freedom is under legal or administrative requirement.
- Group B
- HbA1c ≥ 9%
- Creatinine greater than 1.2 and glomerular filtration rate less than 40
- 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
- Serum liver enzymes (GOT, GPT) above twice the upper limit of normal. Obvious signs or symptoms of liver disease, acute or chronic hepatitis.
- Chronic constipation (stool habit ≥ 7 days)
- Pregnancy or breastfeeding
- 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.
- Immunosuppressant 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.
- Participation in any other study.
- People whose freedom is under legal or administrative requirement.
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Interventions
Patients will begin treatment with metformin administered orally at a starting dose of 425 mg / day every 12 hours for the first 15 days and then continue with a dose of 850 mg / day until the end of the study. The beginning of this treatment phase will be following the recommendations of the clinical guidelines (Comprehensive Approach to Type 2 Diabetes Mellitus, SEEN V2019.2)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04841668