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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 80
Healthy Volunteers: f
View:

• Age between 55 and 80 years.

• Patients with recently diagnosed T2DM (last 6 months), according to the WHO classification.

• Patients in whom written informed consent has been obtained for participation in the study.

• Age between 65 and 80 years.

• Patients with long-term T2DM according to the WHO classification

• Patients in whom written informed consent has been obtained for participation in the study.

Locations
Other Locations
Spain
Institut d'Investigació Biomèdica de Girona (IDIBGI)
RECRUITING
Girona
Contact Information
Primary
José M. Fernández-Real, Ph.D.
jmfreal@idibgi.org
+34 972 94 02 00
Backup
Marisel Rosell Díaz, M.D.
mrosell@idibgi.org
+34 972 94 02 00
Time Frame
Start Date: 2021-04-10
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 136
Treatments
Patients with recently diagnosed T2DM
This group will consist of 36 recently diagnosed T2DM, according to the World Health Organization (WHO) patients (last 6 months), who have not received treatment with metformin.
Patients with long-term T2DM
The group will consist of 100 patients with long-term T2DM, according to the WHO classification, regardless of whether they take metformin or another treatment.
Related Therapeutic Areas
Sponsors
Leads: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

This content was sourced from clinicaltrials.gov