Adipose Tissue Gene Expression and Metabolomics Links to the Gut Microbiome-brain Axis

NCT06869941 | Recruiting

• 1 other identifier: POINSETTIA-2024.200
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Continous Glucose Monitoring; Cognition; Gut-microbiota-brain axis

Outcome Measures

Primary Outcomes (7)

• Glycemic variability

  Mean and standard deviation of glucose measures in mg/dL using a CGM 10 days.

  36 month

• The percentage of time in glucose target range (glucose level 100mg/dl-125mg/dl)

  36 months

• 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.

  36 months

• The glycaemic variability measured with mean amplitude of glycaemic excursions (MAGE)

  measured in mg/dl

  36 months

• Minutes light sleep

  Mean and standard deviation of minutes' light sleep measures by activity and sleep tracker device.

  36 months

• Minutes deep sleep

  Mean and standard deviation of minutes' deep sleep measures by activity and sleep tracker device.

  36 months

• Minutes rapid eye movement (REM)

  Mean and standard deviation of minutes REM measures by activity and sleep tracker device.

  36 months

Secondary Outcomes (43)

• Audioverbal memory

  36 months

• Effect on gut microbiota

  36 months

• Visual memory

  36 months

• Depressive symptomatology

  36 months

• Impulsivity

  36 months

Study Arms (2)

OBESITY

With 2 subgroups * Man with obesity * Women with obesity

WITHOUT OBESITY

With 2 subgroups: * Man without obesity * Women without obesity

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Men and women \>20 years old.
• Scheduled for surgical intervention to extract adipose tissue.
• Signed informed consent for study participation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta: lead

Study Sites (1)

Institut d'Investigació Biomèdica de Girona (IDIBGI)

Girona, Girona, 17007, Spain

RECRUITING

Related Publications (32)

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Biospecimen

Retention: SAMPLES WITH DNA

saliva, stool, blood and urine

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• José Manuel Fernández-Real, M.D., Ph.D.

  Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José Manuel Fernández-Real, M.D., Ph.D.

CONTACT

+34972940200; jmfreal@idibgi.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, clinical professor, section chief of Endocrinology and Nutrition Department of Josep Trueta University Hospital

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

ES (1)