CompletedNot Applicable

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

Spain50 participantsStarted 2021-04-10

Plain-language 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.

Who can participate

Age range

65 Years – 80 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

. 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.

Exclusion criteria

. HbA1c ≥ 9%
. Metformin treatment in the past 6 months
. Creatinine greater than 1.2 and glomerular filtration rate less than 40
. Serious systemic disease not related to obesity, including any type of cancer, severe kidney disease or liver disease, and known type 1 diabetes.

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

Gut microbiota composition.

Timeframe: 12 months

Cognitive impairment

Timeframe: 12 months

Audioverbal memory

Timeframe: 12 months

Visual memory

Timeframe: 12 months

Depressive symptomatology

Timeframe: 12 months

Impulsivity

Timeframe: 12 months

Food Addiction

Timeframe: 12 months

Behavioral inhibition

Timeframe: 12 months

Trial details

NCT IDNCT04841668

SponsorInstitut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-03

View on ClinicalTrials.gov More Type 2 Diabetes Mellitus trials

Plain-language summary

Who can participate

Age range

65 Years – 80 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

. 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.

Exclusion criteria

. HbA1c ≥ 9%
. Metformin treatment in the past 6 months
. Creatinine greater than 1.2 and glomerular filtration rate less than 40
. Serious systemic disease not related to obesity, including any type of cancer, severe kidney disease or liver disease, and known type 1 diabetes.

What they're measuring

Gut microbiota composition.

Timeframe: 12 months

Cognitive impairment

Timeframe: 12 months

Audioverbal memory

Timeframe: 12 months

Visual memory

Timeframe: 12 months

Depressive symptomatology

Timeframe: 12 months

Impulsivity

Timeframe: 12 months

Food Addiction

Timeframe: 12 months

Behavioral inhibition

Timeframe: 12 months