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

NCT05345106 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 138

Last updated 2026-03-31

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Bariatric Surgery

Subjects with obesity (N=60) will be undertaken a hypocaloric diet and a periodic follow up, also 30 of them will undergo bariatric surgery

Sponsors & Collaborators

  • Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

    lead OTHER

Principal Investigators

  • José Manuel Fernández-Real, M.D., Ph.D. · Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-28
Primary Completion
2026-01-22
Completion
2027-01-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05345106 on ClinicalTrials.gov