NCT05345106Active, not recruiting
Inter-relationships Among Glucose, Brain, Gut Microbiota and MicroRNAs (IRONmiRNA).
Inter-relationships Among Iron Stores, the Gut Metagenome, Glucose Levels, and Different Cognitive Domains: the Role of Circulating MicroRNAs (IRONmiRNA Study).
Source: ClinicalTrials.gov · Last updated 31 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 138 (actual)
- First submitted
- 19 Apr 2022
- Start date
- 28 Mar 2022
- Primary completion date
- 22 Jan 2026
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Diseases
- Obesity
- NCT number
- NCT05345106
What you commit to
- Study type: Observational
- Participants enrolled: 138
- From 28 Mar 2022 to the primary completion date, 22 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Excessive alcohol intake, either acute or chronic (alcohol intake greater than 40 g a day (women) or 80 g/day (men)) or drugs abuse.
Other illness
- 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.
- Patients with severe disorders of eating behaviour.
- Major psychiatric antecedents.
- History of disturbances in iron balance (e.g., genetic hemochromatosis, hemosiderosis from any cause, atransferrinemia, paroxysmal nocturnal hemoglobinuria).
Lab values
- Serum liver enzymes (AST, ALT) activity over twice the upper limit of normal.
Other
- Pregnancy and lactation.
- Persons whose liberty is under legal or administrative requirement.
Who the study is looking for
- Men and women aged 30-65 years.
- Informed consent for participation in the study.
Age in the registry: 30 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut d'Investigació Biomèdica de Girona (IDIBGI) Coordinator of this site? Confirm its status | Girona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.