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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study summary

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.

Eligibility

Primary outcome measure(s)

• 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 sleep — 30 months
  Mean and standard deviation of minutes light sleep measures by activity and sleep tracker device.
• Minutes deep sleep — 30 months
  Mean and standard deviation of minutes deep sleep measures by activity and sleep tracker device.
• Minutes rapid eye movement (REM) — 30 months
  Mean and standard deviation of minutes REM measures by activity and sleep tracker device.

Trial sites (1)

More Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta trials in Spain

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