Clinical trial

Inter-relationships Among Glucose, Brain, Gut Microbiota and MicroRNAs (IRONmiRNA).

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05345106

Active, not recruitingNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age30 Years to 65 Years

SexAll

Healthy volunteersAccepted

ConditionObesity

Full registry criteria

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).

Treatments and study arms

Bariatric Surgery

Procedure

Subjects with obesity (N=60) will be undertaken a hypocaloric diet and a periodic follow up, also 30 of them will undergo bariatric surgery

Primary outcomes

Concentration of advanced glycation end products (AGE) receptor agonists.30 months

Enzyme-linked immunosorbent assay (ELISA).

Glycemic variability.30 months

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

The percentage of time in glucose target range (glucose level 100mg/dl-125mg/dl)30 months

The glycaemic risk measured with low blood glucose index (LBGI)30 months

Low blood glucose index (LBGI) is a parameter that quantifies the risk of glycaemic

The glycaemic risk measured with high blood glucose index (HBGI)30 months

High blood glucose index (HBGI) is a parameter that quantifies the risk of glycaemic

The glycaemic variability measured with mean amplitude of glycaemic excursions (MAGE)30 months

measured in mg/dl

Minutes light sleep30 months

Mean and standard deviation of minutes light sleep measures by activity and sleep tracker device.

Minutes deep sleep30 months

Mean and standard deviation of minutes deep sleep measures by activity and sleep tracker device.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Institut d'Investigació Biomèdica de Girona (IDIBGI)🇪🇸 Girona, Girona, Spain

Open map