About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women >20 years old.
Scheduled for surgical intervention to extract adipose tissue.
Signed informed consent for study participation.
Disqualifiers
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.
Trial population
We will make use of the existing samples from the FATBANK cohort (a platform driven by CIBEROBN, managed by the IDIBGI Biobank, and part of the Spanish National Biobank Network). Participants in this cohort had previously signed informed consent to be contacted again. Therefore, the selected participants will be reappointed at the Endocrinology, Diabetes, and Nutrition Service (UDENTG) of the Dr. Josep Trueta Hospital.
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Glycemic variability
Mean and standard deviation of glucose measures in mg/dL using a CGM 10 days.
The percentage of time in glucose target range (glucose level 100mg/dl-125mg/dl)
The glycaemic risk measured with the low blood glucose index (LBGI)
Low blood glucose index (LBGI) is a parameter that quantifies the risk of glycaemic.
The glycaemic variability measured with mean amplitude of glycaemic excursions (MAGE)
measured in mg/dl
Secondary outcomes
Audioverbal memory
It will be measured by California Verbal Learning Test (CVLT). Minimum/maximum scale values (0-16), where 16 is a better audioverbal memory.
Effect on gut microbiota
Gut microbiota will be analysed by metagenomics and metabolomics.
Visual memory
It will be measured by Rey-Osterrieth Complex Figure. Minimum/maximum scale values (0-36), where 36 is a better visual memory.
Depressive symptomatology
It will be measured by Patient Health Questionnaire-9 (PHQ-9). Minimum/maximum scale values (0-27), where ≥ 20 is severe depression.
Sponsors and contacts
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