Inter-relationships Among Glucose, Brain, Gut Microbiota and MicroRNAs (IRONmiRNA). (NCT05345106) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Inter-relationships Among Glucose, Brain, Gut Microbiota and MicroRNAs (IRONmiRNA).
Spain138 participantsStarted 2022-03-28
Plain-language 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.
Who can participate
Age range
30 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Men and women aged 30-65 years.
. Informed consent for participation in the study.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Concentration of advanced glycation end products (AGE) receptor agonists.
Timeframe: 30 months
2
Glycemic variability.
Timeframe: 30 months
3
The percentage of time in glucose target range (glucose level 100mg/dl-125mg/dl)
Timeframe: 30 months
4
The glycaemic risk measured with low blood glucose index (LBGI)
Timeframe: 30 months
5
The glycaemic risk measured with high blood glucose index (HBGI)
Timeframe: 30 months
6
The glycaemic variability measured with mean amplitude of glycaemic excursions (MAGE)
Timeframe: 30 months
7
Minutes light sleep
Timeframe: 30 months
8
Trial details
NCT IDNCT05345106
SponsorInstitut d'Investigació Biomèdica de Girona Dr. Josep Trueta