Obesity Clinical Trial
— IRONmiRNAOfficial title:
Inter-relationships Among Iron Stores, the Gut Metagenome, Glucose Levels, and Different Cognitive Domains: the Role of Circulating MicroRNAs (IRONmiRNA Study).
The brain is a recognized target of iron deposition. This process is enhanced by the presence of obesity and hyperglycemia and impacts cognitive functions. There is evidence suggesting that the gut microbiota composition modulates this process. It has been proposed that microRNAs are mediators in the dialogue between the composition and functionality of the intestinal microbiota and increased iron deposition in the brain. The hypothesis is that circulating microRNAs are associated with parameters of cognitive dysfunction, gut microbiota, brain iron content, glucose levels, and physical activity in subjects with and without obesity. The study includes both a cross-sectional (comparison of subjects with and without obesity) and a longitudinal design (evaluation one year after weight loss induced by bariatric surgery or by diet in patients with obesity) to evaluate the associations between circulating microRNAs, continuous glucose monitoring, brain iron content (by magnetic resonance), cognitive function (by means of cognitive tests), physical activity (measured by activity and sleep tracker device) and the composition of the microbiota, evaluated by metagenomics.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 12, 2024 |
Est. primary completion date | December 12, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Men and women aged 30-65 years. 2. Informed consent for participation in the study. Exclusion Criteria: 1. Serious systemic disease unrelated to obesity such as cancer, severe kidney, or liver disease, known type 1 or type 2 diabetes. 2. Systemic diseases with intrinsic inflammatory activity such as rheumatoid arthritis, Crohn's disease, asthma, chronic infection (e.g., HIV, active tuberculosis) or any type of infectious disease. 3. Pregnancy and lactation. 4. Patients with severe disorders of eating behaviour. 5. Persons whose liberty is under legal or administrative requirement. 6. Clinical symptoms and signs of infection in the previous month. 7. Antibiotic, antifungal or antiviral treatment in the previous 3 months. 8. Anti-inflammatory chronic treatment with steroidal and/or non-steroidal anti-inflammatory drugs. 9. Major psychiatric antecedents. 10. Excessive alcohol intake, either acute or chronic (alcohol intake greater than 40 g a day (women) or 80 g/day (men)) or drugs abuse. 11. Serum liver enzymes (AST, ALT) activity over twice the upper limit of normal. 12. History of disturbances in iron balance (e.g., genetic hemochromatosis, hemosiderosis from any cause, atransferrinemia, paroxysmal nocturnal hemoglobinuria). |
Country | Name | City | State |
---|---|---|---|
Spain | Institut d'Investigació Biomèdica de Girona (IDIBGI) | Girona |
Lead Sponsor | Collaborator |
---|---|
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta |
Spain,
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* Note: There are 39 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concentration of advanced glycation end products (AGE) receptor agonists. | Enzyme-linked immunosorbent assay (ELISA). | 30 months | |
Primary | Glycemic variability. | Mean and standard deviation of glucose measures in mg/dL using a continuous glucose monitoring during 10 days. | 30 months | |
Primary | The percentage of time in glucose target range (glucose level 100mg/dl-125mg/dl) | 30 months | ||
Primary | The glycaemic risk measured with low blood glucose index (LBGI) | Low blood glucose index (LBGI) is a parameter that quantifies the risk of glycaemic | 30 months | |
Primary | The glycaemic risk measured with high blood glucose index (HBGI) | High blood glucose index (HBGI) is a parameter that quantifies the risk of glycaemic | 30 months | |
Primary | The glycaemic variability measured with mean amplitude of glycaemic excursions (MAGE) | measured in mg/dl | 30 months | |
Primary | Minutes light sleep | Mean and standard deviation of minutes light sleep measures by activity and sleep tracker device. | 30 months | |
Primary | Minutes deep sleep | Mean and standard deviation of minutes deep sleep measures by activity and sleep tracker device. | 30 months | |
Primary | Minutes rapid eye movement (REM) | Mean and standard deviation of minutes REM measures by activity and sleep tracker device. | 30 months | |
Secondary | Effect on brain structure. | Brain structure will be assessed using magnetic resonance imaging. | 30 months | |
Secondary | Effect on gut microbiota. | Gut microbiota will be analysed by metagenomics and metabolomics. | 30 months | |
Secondary | Changes from baseline in circulating concentration of AGE receptor agonists and glycemic variability one year of follow-up after weight loss in association with changes in brain structure and gut microbiota. | Subjects with obesity will be undertaken conventional treatment or bariatric surgery for weight loss; controls will not undergo any additional measure. | 30 months | |
Secondary | Anxiety state | It will be measured by State-Trate Anxiety Inventory (STAI). | 30 months | |
Secondary | 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. | 30 months | |
Secondary | Visual memory | It will be measured by Rey-Osterrieth Complex Figure. Minimum/maximum scale values (0-36), where 36 is a better visual memory | 30 months | |
Secondary | Depressive symptomatology | It will be measured by Patient Health Questionnaire-9 (PHQ-9). Minimum/maximum scale values (0-27), where = 20 is severe depression. | 30 months | |
Secondary | Impulsivity | It will be measured by Impulsive Behavior Scale (UPPS-P). The test evaluates: Negative | 30 months | |
Secondary | 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. | 30 months | |
Secondary | Behavioral inhibition | It will be measured by Sensitivity to Punishment and Sensitivity to Reward (SPSRQ). The scale of sensitivity to punishment is related to the behavioral inhibition system. It is made up of two subscales of 24 items each, where the higher the score, the greater the sensitivity to punishment. | 30 months | |
Secondary | Behavioral activation | It will be measured by Sensitivity to Punishment and Sensitivity to Reward (SPSRQ). The reward sensitivity scale is related to the behavioral activation system. It is made up of two subscales of 24 items each, where the higher the score, the greater the sensitivity to reward. | 30 months | |
Secondary | Visoconstructive function | It will be measured by Rey-Osterrieth Complex Figure. Minimum/maximum scale values (0-36), where 36 is a better visoconstructive function. | 30 months | |
Secondary | Selective and alternating attention | It will be measured by Trail making test (Part A y B). | 30 months | |
Secondary | Attention and working memory | It will be measured by the Digits subtest of Wechsler Adult Intelligence Scales, Fourth Edition (WAIS-IV). | 30 months | |
Secondary | Inhibition | It will be measured by Stroop Color-Word Test. | 30 months | |
Secondary | Phonemic verbal fluency | It will be measured by PMR. | 30 months | |
Secondary | 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. | 30 months | |
Secondary | Facial recognition | It will be measured by Picture of Facial Recognition Test (POFA). | 30 months | |
Secondary | 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. | 30 months | |
Secondary | 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. | 30 months | |
Secondary | Brain iron accumulation | It will be assessed using magnetic resonance imaging using (R2*) | 30 months | |
Secondary | 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 value of T2 * will be calculated by adjusting the simple exponential terms for the signal decay of the respective echo time values. | 30 months | |
Secondary | Insulin resistance | It will be measured by HOMA | 30 months | |
Secondary | Markers of chronic inflammation: C-reactive protein, IL-6, adiponectin and soluble, tumor necrosis factor-a receptor fractions. | Enzyme-linked immunosorbent assay (ELISA) and quantitative polymerase chain reaction (qPCR) | 30 months | |
Secondary | Glycosylated hemoglobin (HbA1c) value | Glycosylated hemoglobin (HbA1c) in % or mmol/mol | 30 months | |
Secondary | The percentage of time in hyperglycaemia (glucose level above 250 mg/dl) | 30 months | ||
Secondary | The percentage of time in hypoglycaemia (glucose level below 70mg/dl) | 30 months | ||
Secondary | The percentage of time in glucose range (glucose level below 100 mg/dl) | 30 months | ||
Secondary | The percentage of time in glucose range (glucose level between 126-139 mg/dl) | 30 months | ||
Secondary | The percentage of time in glucose range (glucose level between 140-199 mg/dl) | 30 months | ||
Secondary | The percentage of time in glucose range (glucose level above 200 mg/dl) | 30 months | ||
Secondary | Burned calories | Mean and standard deviation of burned calories measures by activity and sleep tracker device. | 30 months | |
Secondary | Steps | Mean and standard deviation of steps measures by activity and sleep tracker device. | 30 months | |
Secondary | Distance | Mean and standard deviation of distance measures by activity and sleep tracker device. | 30 months | |
Secondary | Minutes null activity | Mean and standard deviation of minutes null activity measures by activity and sleep | 30 months | |
Secondary | Minutes slight activity | Mean and standard deviation of minutes slight activity measures by activity and sleep | 30 months | |
Secondary | Minutes mean activity | Mean and standard deviation of minutes mean activity measures by activity and sleep tracker device. | 30 months | |
Secondary | Minutes high activity | Mean and standard deviation of minutes high activity measures by activity and sleep tracker device. | 30 months | |
Secondary | Calories | Mean and standard deviation of calories measures by activity and sleep tracker device. | 30 months | |
Secondary | Minutes asleep | Mean and standard deviation of minutes asleep measures by activity and sleep tracker | 30 months | |
Secondary | Minutes awake | Mean and standard deviation of minutes awake measures by activity and sleep tracker | 30 months | |
Secondary | Bed time | Mean and standard deviation of bed time measures by activity and sleep tracker device. | 30 months | |
Secondary | Number time awake | Mean and standard deviation of number time awake measures by activity and sleep | 30 months |
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