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

NCT05345106 | Active Not Recruiting

• 1 other identifier: IRONmiRNA-2022.043
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

Continous Glucose Monitoring; Cognition; Brain Iron content

Outcome Measures

Primary Outcomes (9)

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

  Enzyme-linked immunosorbent assay (ELISA).

  30 months

• Glycemic variability.

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

  30 months

• 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)

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

  30 months

• 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

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

  measured in mg/dl

  30 months

• Minutes light sleep

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

  30 months

• Minutes deep sleep

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

  30 months

• Minutes rapid eye movement (REM)

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

  30 months

Secondary Outcomes (43)

• Effect on brain structure.

  30 months

• Effect on gut microbiota.

  30 months

• 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.

  30 months

• Anxiety state

  30 months

• Audioverbal memory

  30 months

Study Arms (6)

Premenopausal women with obesity

Procedure: Bariatric Surgery

Postmenopausal women with obesity

Procedure: Bariatric Surgery

Men with obesity

Procedure: Bariatric Surgery

Premenopausal women without obesity

Postmenopausal women without obesity

Men without obesity

Interventions

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

Men with obesity; Postmenopausal women with obesity; Premenopausal women with obesity

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with obesity, without known type 2 diabetes, previously scheduled at the Service of Endocrinology, Diabetes and Nutrition (UDEN) of the Hospital "Dr. Josep Trueta" of Girona (Spain) will be recruited and studied. Subjects without obesity will also be recruited through a public announcement.

You may qualify if:

• Men and women aged 30-65 years.
• Informed consent for participation in the study.

You may not qualify if:

• Serious systemic disease unrelated to obesity such as cancer, severe kidney, or liver disease, known type 1 or type 2 diabetes.
• 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.
• Pregnancy and lactation.
• Patients with severe disorders of eating behaviour.
• Persons whose liberty is under legal or administrative requirement.
• Clinical symptoms and signs of infection in the previous month.
• Antibiotic, antifungal or antiviral treatment in the previous 3 months.
• Anti-inflammatory chronic treatment with steroidal and/or non-steroidal anti-inflammatory drugs.
• Major psychiatric antecedents.
• Excessive alcohol intake, either acute or chronic (alcohol intake greater than 40 g a day (women) or 80 g/day (men)) or drugs abuse.
• Serum liver enzymes (AST, ALT) activity over twice the upper limit of normal.
• History of disturbances in iron balance (e.g., genetic hemochromatosis, hemosiderosis from any cause, atransferrinemia, paroxysmal nocturnal hemoglobinuria).

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta: lead

Study Sites (1)

Institut d'Investigació Biomèdica de Girona (IDIBGI)

Girona, Girona, 17007, Spain

Location

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MeSH Terms

Conditions

Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• José Manuel Fernández-Real, M.D., Ph.D.

  Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, clinical professor, section chief of Endocrinology and Nutrition Department of Josep Trueta University Hospital

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 25, 2022
• Study Start: March 28, 2022
• Primary Completion: January 22, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

ES (1)