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Gut-Brain-axis: Targets for Improvement of Cognition in the Elderly

NCT04841668 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-03-31

No results posted yet for this study

Summary

Cognitive disorders increase with age and in the presence of metabolic diseases such as Type 2 Diabetes Mellitus (T2DM). In addition, digestive disorders, changes in dietary pattern and decreased activity negatively influence the microbiome.

The hypothesis is that pharmacological intervention with metformin will modify the composition of the gut microbiota and cognition.

The study has a pilot longitudinal design, where each patient with T2DM will be followed for one year. Two groups will be recruited:

1. Group A: The aim will be to evaluate the associations between glucose (measured by continuous glucose monitoring (CGM)), cognitive function (by means of cognitive tests and magnetic resonance imaging (MRI)), physical activity (recorded by activity and sleep tracker devicer), metformin, diet (evaluated by nutritional survey) and composition of the microbiota (evaluated by metagenomics), during 12 months (6 months without metformin and 6 months with metformin treatment).
2. Group B: The aim will be to evaluate the associations between glucose, diet (evaluated by nutritional survey), cognitive function (by means of cognitive tests), physical activity (measured by activity and sleep tracker device), the treatment and composition of the microbiota (evaluated by metagenomics), during 12 months.

Conditions

Interventions

DRUG

Metformin

Patients will begin treatment with metformin administered orally at a starting dose of 425 mg / day every 12 hours for the first 15 days and then continue with a dose of 850 mg / day until the end of the study. The beginning of this treatment phase will be following the recommendations of the clinical guidelines (Comprehensive Approach to Type 2 Diabetes Mellitus, SEEN V2019.2)

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • José M Fernández-Real, Ph.D. · Institut d'Investigació Biomèdica de Girona (IDIBGI)

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-10
Primary Completion
2024-12-03
Completion
2024-12-03

Countries

  • Spain

Study Locations

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Entities

Drugs
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 NCT04841668 on ClinicalTrials.gov