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

Last updated: March 10, 2025
Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Obesity

Treatment

N/A

Clinical Study ID

NCT06869941
POINSETTIA-2024.200
  • Ages > 20
  • All Genders

Study 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 like 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.

In this study, we want to explore how gene expression in adipose tissue, blood metabolites, and the gut microbiota are related to cognitive function, such as memory and thinking, in people with and without obesity. We will also investigate if these factors can predict changes in the brain over the years and how they affect sleep, physical activity, and blood sugar control.

We will use advanced technologies to analyze samples of tissue, blood, and microbiota, with the goal of identifying new ways to understand how obesity affects the brain. This study could help find new ways of diagnosing and treating cognitive problems in people with obesity.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and women >20 years old.

  • Scheduled for surgical intervention to extract adipose tissue.

  • Signed informed consent for study participation.

Exclusion

Exclusion Criteria:

  • Not meeting inclusion criteria.

  • Non-obesity-related systemic diseases (cancer, severe kidney/liver disease).

  • Systemic diseases with intrinsic inflammation (rheumatoid arthritis, Crohn'sdisease, asthma, chronic infections (HIV/tuberculosis)) or any type of infectiousdisease.

  • 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)) ordrug abuse.

  • Immunosuppressants treatment.

  • Participants with severe eating disorders.

  • Serum liver enzymes (GOT, GPT) above twice the upper limit of normal. Obvious signsor symptoms of liver disease, acute or chronic hepatitis.

  • History of iron balance disorders (e.g., genetic hemochromatosis, hemosiderosis fromany 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 cellskin 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) .

Study Design

Total Participants: 100
Study Start date:
April 01, 2025
Estimated Completion Date:
April 30, 2028

Connect with a study center

  • Institut d'Investigació Biomèdica de Girona (IDIBGI)

    Girona, 17007
    Spain

    Active - Recruiting

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