An observational study in Obesity, sponsored by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta. Recruiting at 1 site in Spain. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta · Observational
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 100 is below the median of 114 across 2,154 observational studies indexed under Obesity.
Browse Obesity studies →Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta is the lead sponsor of 31 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
With 2 subgroups * Man with obesity * Women with obesity
With 2 subgroups: * Man without obesity * Women without obesity
Glycemic variability
Mean and standard deviation of glucose measures in mg/dL using a CGM 10 days.
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)
Low blood glucose index (LBGI) is a parameter that quantifies the risk of glycaemic.
Time frame: 36 months
The glycaemic variability measured with mean amplitude of glycaemic excursions (MAGE)
measured in mg/dl
Time frame: 36 months
Minutes light sleep
Mean and standard deviation of minutes' light sleep measures by activity and sleep tracker device.
Time frame: 36 months
Minutes deep sleep
Mean and standard deviation of minutes' deep sleep measures by activity and sleep tracker device.
Time frame: 36 months
Minutes rapid eye movement (REM)
Mean and standard deviation of minutes REM measures by activity and sleep tracker device.
Time frame: 36 months
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
Effect on gut microbiota
Gut microbiota will be analysed by metagenomics and metabolomics.
Time frame: 36 months
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
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
Impulsivity
It will be measured by Impulsive Behaviour Scale (UPPS-P). The test evaluates: Negative urgency (tendency to act rashly under extreme negative emotions), Lack of Premeditation (tendency to act without thinking), Lack of Perseverance (inability to remain focused on a task) and Sensation Seeking (tendency to seek out novel and thrilling experiences). All items are rated on a four point scale from 1 (strongly agree) to 4 (strongly disagree).
Time frame: 36 months
Food Addiction
It will be measured by Yale Food Addiction Scale. It is a symptom score from 0-11, based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria, for substance dependence. Food addiction is diagnosed if ≥3 symptoms are reported.
Time frame: 36 months
Behavioural inhibition
It will be measured by Sensitivity to Punishment and Sensitivity to Reward (SPSRQ). The scale of Sensitivity to Punishment is related to the behavioural inhibition system. It is made up of two subscales of 24 items each. For each subscale, the minimum score is 0 and the maximum score is 24, with higher scores indicating greater sensitivity to punishment or reward, respectively.
Time frame: 36 months
Behavioural activation
It will be measured by Sensitivity to Punishment and Sensitivity to Reward (SPSRQ). The reward sensitivity scale is related to the behavioural activation system. The questionnaire consists of two subscales of 24 items each. Each subscale ranges from 0 (minimum) to 24 (maximum), where a higher score indicates greater sensitivity to reward or punishment, respectively.
Time frame: 36 months
Visoconstructive function
It will be measured by Rey-Osterrieth Complex Figure. Minimum/maximum scale values (0-36), where 36 is a better visoconstructive function.
Time frame: 36 months
Selective and alternating attention
It will be measured by Trail making test (Part A and B).
Time frame: 36 months
Attention and working memory
It will be measured by the Digits subtest of the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV). This subtest includes two parts: Digits Forward (measuring attention) and Digits Backward (measuring working memory). The total raw score ranges from 0 (minimum) to 30 (maximum), with higher scores indicating better attention and working memory capacity.
Time frame: 36 months
Inhibition
It will be measured by Stroop Color-Word Test.
Time frame: 36 months
Phonemic verbal fluency
It will be measured by PMR.
Time frame: 36 months
Semantic verbal fluency
It will be measured by Animals test. The person must name as many animals as possible in 1 minute. The result is corrected by standard scores, according to age and level of education.
Time frame: 36 months
Facial recognition
It will be measured by Picture of Facial Recognition Test (POFA).
Time frame: 36 months
Emotion recognition
It will be measured by Benton Facial Recognition Test (BFRT). This test evaluates the recognition of the five basic emotions: happiness, sadness, surprise, disgust, and anger.
Time frame: 36 months
Binge eating disorder
It will be measured by Binge Eating Scale (BES). The BES is one of the most widely used measures to assess binge eating disorder symptomatology. The BES score ranges from 0 to 46 and its cut-off point is greater than or equal to 27. Subjects with scores higher than 27 are more likely to suffer from binge eating disorder.
Time frame: 36 months
Anxiety state
It will be measured by State-Trate Anxiety Inventory (STAI). This questionnaire evaluates state anxiety (S) and trait anxiety (R) through 20 items each, with a likert-type response scale of four alternatives. In the case of state anxiety, the scale goes from 0 (not at all) to 3 (a lot), while for trait anxiety it goes from 0 (almost never) to 3 (almost always). The higher the score, the greater the anxiety in both concepts.
Time frame: 36 months
Effect on brain structure
Brain structure will be assessed using magnetic resonance imaging.
Time frame: 36 months
Diffusion Tensor Imaging brain sequences
Diffusion Tensor Imaging was acquired at 1.5 T (Philips ingenia) using a single-shot spin echo sequence with echo-planar imaging (EPI), 50 contiguous slices, voxel size 2x2x2.5 mm3, TE/TR of 72/3581 ms/ms, a diffusion-weighting factor b = 800 s/mm2 and diffusion encoding along 32 directions.
Time frame: 36 months
Brain iron accumulation
It will be assessed using magnetic resonance imaging using (R2\*)
Time frame: 36 months
Resting-state functional brain sequences
It will be assessed using magnetic resonance imaging (T2\*-weighted echo-planar imaging). T2 \* relaxation data will be acquired with a multi-echo gradient sequence with 10 equidistant echoes (first echo = 4.6ms; echo spacing = 4.6ms; repetition time = 1300ms). The value of T2 \* will be calculated by adjusting the simple exponential terms for the signal decay of the respective echo time values.
Time frame: 36 months
Insulin resistance
It will be measured by HOMA
Time frame: 36 months
Markers of chronic inflammation (C-reactive protein, IL-6, adiponectin and soluble, tumour necrosis factor-α receptor fractions)
Enzyme-linked immunosorbent assay (ELISA) and quantitative polymerase chain reaction (qPCR)
Time frame: 36 months
Glycosylated haemoglobin (HbA1c) value
Glycosylated haemoglobin (HbA1c) in % or mmol/mol
Time frame: 36 months
The percentage of time in hyperglycaemia (glucose level above 250 mg/dl)
Time frame: 36 months
The percentage of time in hypoglycaemia (glucose level below 70mg/dl)
Time frame: 36 months
The percentage of time in glucose range (glucose level below 100 mg/dl)
Time frame: 36 months
The percentage of time in glucose range (glucose level between 126-139 mg/dl)
Time frame: 36 months
The percentage of time in glucose range (glucose level between 140-199 mg/dl)
Time frame: 36 months
The percentage of time in glucose range (glucose level above 200 mg/dl)
Time frame: 36 months
Burned calories
Mean and standard deviation of burned calories measures by activity and sleep tracker device.
Time frame: 36 months
Steps Mean and standard deviation of steps measures by activity and sleep tracker device.
The mean and standard deviation of steps refer to the average number of steps taken by a participant and how much those steps vary from the average, as measured by an activity and sleep tracker device. The mean is the average, while the standard deviation shows the variation or consistency in step count.
Time frame: 36 months
Distance Mean and standard deviation of distance measures by activity and sleep tracker device.
Time frame: 36 months
Minutes null activity
Mean and standard deviation of minutes' null activity measures by activity and sleep
Time frame: 36 months
Minutes slight activity
Mean and standard deviation of minutes slight activity measures by activity and sleep
Time frame: 36 months
Minutes mean activity
Mean and standard deviation of minutes mean activity measures by activity and sleep tracker device.
Time frame: 36 months
Minutes high activity
Mean and standard deviation of minutes high activity measures by activity and sleep tracker device.
Time frame: 36 months
Calories
Mean and standard deviation of calories measures by activity and sleep tracker device.
Time frame: 36 months
Minutes asleep
Mean and standard deviation of minutes asleep measures by activity and sleep tracker.
Time frame: 36 months
Minutes awake
Mean and standard deviation of minutes awake measures by activity and sleep tracker.
Time frame: 36 months
Bed time Mean and standard deviation of bed time measures by activity and sleep tracker device.
Time frame: 36 months
Number time awake Mean and standard deviation of number time awake measures by activity and sleep
Time frame: 36 months
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Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta