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

Launched by INSTITUT D'INVESTIGACIÓ BIOMÈDICA DE GIRONA DR. JOSEP TRUETA · Apr 19, 2022

Keywords

ClinConnect Summary

The clinical trial titled "Inter-relationships Among Glucose, Brain, Gut Microbiota and MicroRNAs (IRONmiRNA)" is exploring how factors like obesity, brain health, and gut bacteria relate to each other. Researchers believe that certain small molecules called microRNAs could play a role in how obesity affects brain iron levels and cognitive functions. This study aims to see if there are connections between these microRNAs and aspects like brain iron content, glucose levels, and physical activity in people with and without obesity.

To be eligible for this trial, participants should be men and women aged 30 to 65 years who agree to take part in the study. However, individuals with serious illnesses unrelated to obesity, certain systemic diseases, or those currently pregnant or with eating disorders cannot participate. If you join, you’ll undergo various tests, including cognitive assessments and monitoring of your physical activity, and your gut bacteria will be analyzed. The study is currently recruiting participants, and it will help us understand the complex relationships between obesity, brain health, and gut microbiota, which could lead to better treatments in the future.

Gender

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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).