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

ConditionObesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorInstitut d'Investigació Biomèdica de Girona Dr. Josep Trueta

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: OBESITY
Group B: WITHOUT OBESITY

Trial outcomes

Primary outcomes

1

Glycemic variability

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

Time frame
36 month
2

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

Time frame
36 months
3

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.

Time frame
36 months
4

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

measured in mg/dl

Time frame
36 months

Secondary outcomes

1

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.

Time frame
36 months
2

Effect on gut microbiota

Gut microbiota will be analysed by metagenomics and metabolomics.

Time frame
36 months
3

Visual memory

It will be measured by Rey-Osterrieth Complex Figure. Minimum/maximum scale values (0-36), where 36 is a better visual memory.

Time frame
36 months
4

Depressive symptomatology

It will be measured by Patient Health Questionnaire-9 (PHQ-9). Minimum/maximum scale values (0-27), where ≥ 20 is severe depression.

Time frame
36 months

Other outcomes

Sponsors and contacts

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