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Recruiting NCT06869941

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

— Observational Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Obesity. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Adipose Tissue Gene Expression and Metabolomics Links to the Gut Microbiome-brain Axis (POINSETTIA Study)

Overview

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.

Primary outcome measures

  • Glycemic variability [Time frame: 36 month]
  • The percentage of time in glucose target range (glucose level 100mg/dl-125mg/dl) [Time frame: 36 months]
  • The glycaemic risk measured with the low blood glucose index (LBGI) [Time frame: 36 months]
  • The glycaemic variability measured with mean amplitude of glycaemic excursions (MAGE) [Time frame: 36 months]
  • Minutes light sleep [Time frame: 36 months]
  • Minutes deep sleep [Time frame: 36 months]
  • Minutes rapid eye movement (REM) [Time frame: 36 months]
Secondary outcome measures (12)
  • Audioverbal memory [Time frame: 36 months]
  • Effect on gut microbiota [Time frame: 36 months]
  • Visual memory [Time frame: 36 months]
  • Depressive symptomatology [Time frame: 36 months]
  • Impulsivity [Time frame: 36 months]
  • Food Addiction [Time frame: 36 months]
  • Behavioural inhibition [Time frame: 36 months]
  • Behavioural activation [Time frame: 36 months]
  • Visoconstructive function [Time frame: 36 months]
  • Selective and alternating attention [Time frame: 36 months]
  • Attention and working memory [Time frame: 36 months]
  • Inhibition [Time frame: 36 months]

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) .

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Spain · 1 center
  • Institut d'Investigació Biomèdica de Girona (IDIBGI) — Girona

Publications

  • Mayneris-Perxachs J, Arnoriaga-Rodriguez M, Garre-Olmo J, Puig J, Ramos R, Trelis M, Burokas A, Coll C, Zapata-Tona C, Pedraza S, Perez-Brocal V, Ramio L, Ricart W, Moya A, Jove M, Sol J, Portero-Otin M, Pamplona R, Maldonado R, Fernandez-Real JM. Presence of Blastocystis in gut microbiota is associated with cognitive traits and decreased executive function. ISME J. 2022 Sep;16(9):2181-2197. doi: PMID 35729225
  • Bier E. Drosophila, the golden bug, emerges as a tool for human genetics. Nat Rev Genet. 2005 Jan;6(1):9-23. doi: 10.1038/nrg1503. PMID 15630418
  • Douglas AE. The Drosophila model for microbiome research. Lab Anim (NY). 2018 Jun;47(6):157-164. doi: 10.1038/s41684-018-0065-0. Epub 2018 May 23. PMID 29795158
  • Quesada-Vazquez S, Castells-Nobau A, Latorre J, Oliveras-Canellas N, Puig-Parnau I, Tejera N, Tobajas Y, Baudin J, Hildebrand F, Beraza N, Burcelin R, Martinez-Gili L, Chilloux J, Dumas ME, Federici M, Hoyles L, Caimari A, Del Bas JM, Escote X, Fernandez-Real JM, Mayneris-Perxachs J. Potential therapeutic implications of histidine catabolism by the gut microbiota in NAFLD patients with morbid obes PMID 38118419
  • Mayneris-Perxachs J, Moreno-Navarrete JM, Ballanti M, Monteleone G, Alessandro Paoluzi O, Mingrone G, Lefebvre P, Staels B, Federici M, Puig J, Garre J, Ramos R, Fernandez-Real JM. Lipidomics and metabolomics signatures of SARS-CoV-2 mediators/receptors in peripheral leukocytes, jejunum and colon. Comput Struct Biotechnol J. 2021;19:6080-6089. doi: 10.1016/j.csbj.2021.11.007. Epub 2021 Nov 8. PMID 34777716
  • Lin H, Peddada SD. Analysis of compositions of microbiomes with bias correction. Nat Commun. 2020 Jul 14;11(1):3514. doi: 10.1038/s41467-020-17041-7. PMID 32665548
  • Albanese D, Donati C. Strain profiling and epidemiology of bacterial species from metagenomic sequencing. Nat Commun. 2017 Dec 22;8(1):2260. doi: 10.1038/s41467-017-02209-5. PMID 29273717
  • Zhao S, Li H, Han W, Chan W, Li L. Metabolomic Coverage of Chemical-Group-Submetabolome Analysis: Group Classification and Four-Channel Chemical Isotope Labeling LC-MS. Anal Chem. 2019 Sep 17;91(18):12108-12115. doi: 10.1021/acs.analchem.9b03431. Epub 2019 Sep 5. PMID 31441644

Identifiers

NCT: NCT06869941 · POINSETTIA-2024.200

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗