Adipose Tissue Gene Expression and Metabolomics Links to the Gut Microbiome-brain Axis
Recruiting · NCT06869941 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
This study aims to understand how adipose tissue (fat) and the gut microbiota (the bacteria in the gut) may influence brain function and cognition. It has been observed that changes in adipose tissue in animals such as mice and Drosophila (a type of insect) affect memory and other brain functions. Additionally, it is believed that the gut microbiota also plays an important role in cognition. This study will explore how gene expression in adipose tissue, blood metabolites, and the gut microbiota are related to cognitive function, such as memory and thinking, in individuals with and without obesity. The investigation will also assess whether these factors can predict changes in the brain over time and how they influence sleep, physical activity, and blood sugar regulation. Advanced technologies will be used to analyze samples of tissue, blood, and microbiota, with the goal of identifying new mechanisms through which obesity affects the brain. This research may contribute to the development of new diagnostic and therapeutic strategies for cognitive problems in individuals with obesity.
Who can take part
Inclusion criteria
- Men and women \>20 years old.
- Scheduled for surgical intervention to extract adipose tissue.
- Signed informed consent for study participation.
Exclusion criteria
- Not meeting inclusion criteria.
- Non-obesity-related systemic diseases (cancer, severe kidney/liver disease).
- Systemic diseases with intrinsic inflammation (rheumatoid arthritis, Crohn's disease, asthma, chronic infections (HIV/tuberculosis)) or any type of infectious disease.
- Pregnant/breastfeeding women.
- Persons under legal/administrative restrictions.
- Those with infection symptoms in the past month.
- Use of antibiotics/antifungals/antivirals (previous 3 months).
- Chronic steroidal/anti-inflammatory drug use.
- Major psychiatric history.
- Excessive alcohol intake, acute or chronic (\>40g/day (women), \>80g/day (men)) or drug abuse.
- Immunosuppressants treatment.
- Participants with severe eating disorders.
- Serum liver enzymes (GOT, GPT) above twice the upper limit of normal. Obvious signs or symptoms of liver disease, acute or chronic hepatitis.
- History of iron balance disorders (e.g., genetic hemochromatosis, hemosiderosis from any cause, atransferrinemia, paroxysmal nocturnal hemoglobinuria).
- Creatinine greater than 1.2 and glomerular filtration rate below 40.
- Current treatment for malignant neoplasia, other than basal cell or squamous cell skin cancer.
- Heart disease classified as class III or IV, known ischemic cardiovascular disease.
- Renal failure, history of kidney transplant, or current dialysis treatment.
- Chronic constipation (bowel movement frequency ≥ 7 days) .
Where it is running
1 location listed.
- Institut d'Investigació Biomèdica de Girona (IDIBGI) - Girona, Girona, Spain