Clinical trial NCT06869941: Adipose Tissue Gene Expression and Metabolomics Links to the Gut Microbiome-brain Axis
Official title: Adipose Tissue Gene Expression and Metabolomics Links to the Gut Microbiome-brain Axis (POINSETTIA Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Keywords: Continous Glucose Monitoring
Cognition
Gut-microbiota-brain axis
Lead sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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: 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) .

Primary outcomes:
measure: Glycemic variability
timeFrame: 36 month
measure: The percentage of time in glucose target range (glucose level 100mg/dl-125mg/dl)
timeFrame: 36 months
measure: The glycaemic risk measured with the low blood glucose index (LBGI)
timeFrame: 36 months
measure: The glycaemic variability measured with mean amplitude of glycaemic excursions (MAGE)
timeFrame: 36 months
measure: Minutes light sleep
timeFrame: 36 months
measure: Minutes deep sleep
timeFrame: 36 months
measure: Minutes rapid eye movement (REM)
timeFrame: 36 months
Secondary outcomes:
measure: Audioverbal memory
timeFrame: 36 months
measure: Effect on gut microbiota
timeFrame: 36 months
measure: Visual memory
timeFrame: 36 months
measure: Depressive symptomatology
timeFrame: 36 months
measure: Impulsivity
timeFrame: 36 months
measure: Food Addiction
timeFrame: 36 months
measure: Behavioural inhibition
timeFrame: 36 months
measure: Behavioural activation
timeFrame: 36 months
measure: Visoconstructive function
timeFrame: 36 months
measure: Selective and alternating attention
timeFrame: 36 months
measure: Attention and working memory
timeFrame: 36 months
measure: Inhibition
timeFrame: 36 months
measure: Phonemic verbal fluency
timeFrame: 36 months
measure: Semantic verbal fluency
timeFrame: 36 months
measure: Facial recognition
timeFrame: 36 months
measure: Emotion recognition
timeFrame: 36 months
measure: Binge eating disorder
timeFrame: 36 months
measure: Anxiety state
timeFrame: 36 months
measure: Effect on brain structure
timeFrame: 36 months
measure: Diffusion Tensor Imaging brain sequences
timeFrame: 36 months
measure: Brain iron accumulation
timeFrame: 36 months
measure: Resting-state functional brain sequences
timeFrame: 36 months
measure: Insulin resistance
timeFrame: 36 months
measure: Markers of chronic inflammation (C-reactive protein, IL-6, adiponectin and soluble, tumour necrosis factor-α receptor fractions)
timeFrame: 36 months
measure: Glycosylated haemoglobin (HbA1c) value
timeFrame: 36 months
measure: The percentage of time in hyperglycaemia (glucose level above 250 mg/dl)
timeFrame: 36 months
measure: The percentage of time in hypoglycaemia (glucose level below 70mg/dl)
timeFrame: 36 months
measure: The percentage of time in glucose range (glucose level below 100 mg/dl)
timeFrame: 36 months
measure: The percentage of time in glucose range (glucose level between 126-139 mg/dl)
timeFrame: 36 months
measure: The percentage of time in glucose range (glucose level between 140-199 mg/dl)
timeFrame: 36 months
measure: The percentage of time in glucose range (glucose level above 200 mg/dl)
timeFrame: 36 months
measure: Burned calories
timeFrame: 36 months
measure: Steps Mean and standard deviation of steps measures by activity and sleep tracker device.
timeFrame: 36 months
measure: Distance Mean and standard deviation of distance measures by activity and sleep tracker device.
timeFrame: 36 months
measure: Minutes null activity
timeFrame: 36 months
measure: Minutes slight activity
timeFrame: 36 months
measure: Minutes mean activity
timeFrame: 36 months
measure: Minutes high activity
timeFrame: 36 months
measure: Calories
timeFrame: 36 months
measure: Minutes asleep
timeFrame: 36 months
measure: Minutes awake
timeFrame: 36 months
measure: Bed time Mean and standard deviation of bed time measures by activity and sleep tracker device.
timeFrame: 36 months
measure: Number time awake Mean and standard deviation of number time awake measures by activity and sleep
timeFrame: 36 months
Other outcomes:
Locations:
city: Girona
country: Spain
facility: Institut d'Investigació Biomèdica de Girona (IDIBGI)
Study officials:
affiliation: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
name: José Manuel Fernández-Real, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
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