Status:
RECRUITING
Inter-relationships Among Glucose, Brain, Gut Microbiota and MicroRNAs (IRONmiRNA).
Lead Sponsor:
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Conditions:
Obesity
Eligibility:
All Genders
30-65 years
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 mi...
Detailed Description
Subjects and methods: A. Cross-sectional study: Patients with obesity previously scheduled at the Service of Endocrinology, Diabetes, and Nutrition (UDEN) of the Hospital "Dr. Josep Trueta" of Giron...
Eligibility Criteria
Inclusion
- Men and women aged 30-65 years.
- Informed consent for participation in the study.
Exclusion
- 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).
Key Trial Info
Start Date :
March 28 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 12 2026
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT05345106
Start Date
March 28 2022
End Date
December 12 2026
Last Update
December 12 2025
Active Locations (1)
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1
Institut d'Investigació Biomèdica de Girona (IDIBGI)
Girona, Girona, Spain, 17007