Exploring the links between glucose, brain health, gut microbiota, and microRNAs in obesity

Inter-relationships Among Iron Stores, the Gut Metagenome, Glucose Levels, and Different Cognitive Domains: the Role of Circulating MicroRNAs (IRONmiRNA Study).

This study is trying to see how glucose levels, gut bacteria, and certain molecules in the body affect brain health in people with and without obesity.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 30 Years to 65 Years
• Sex: All
• Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (Academic / other)
• Locations: 1 site (Girona)
• Trial ID: NCT05345106 on ClinicalTrials.gov

What this trial studies

This observational study investigates the relationships among glucose levels, brain iron content, gut microbiota, and circulating microRNAs in individuals with and without obesity. It employs both cross-sectional and longitudinal designs, including a ten-day continuous glucose monitoring period and cognitive assessments. Participants will undergo magnetic resonance imaging to evaluate brain iron content and provide biological samples for microbiota analysis. The study aims to understand how these factors interact and contribute to cognitive dysfunction associated with obesity.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 30-65 years, with or without obesity, who can provide informed consent.

Not a fit: Patients with serious systemic diseases unrelated to obesity, major psychiatric disorders, or those currently undergoing specific treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new insights into the mechanisms linking obesity with cognitive dysfunction, potentially informing future therapeutic strategies.

How similar studies have performed: While the specific inter-relationships being studied are novel, previous studies have shown that gut microbiota and glucose levels can influence cognitive functions, suggesting potential for success.

Eligibility 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).

Where this trial is running

Girona

• Institut d'Investigació Biomèdica de Girona (IDIBGI) — Girona, Spain (Recruiting)

Study contacts

• Principal investigator: José Manuel Fernández-Real, M.D., Ph.D. — Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Study coordinator: José Manuel Fernández-Real, M.D., Ph.D.

Conditions Obesity; Continous Glucose Monitoring; Cognition; Brain Iron content