SGLT2 Inhibitors and Cognitive Function in Adults With Type 2 Diabetes (SaveMinD) (NCT07694596) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
SGLT2 Inhibitors and Cognitive Function in Adults With Type 2 Diabetes (SaveMinD)
Slovenia200 participantsStarted 2026-06-20
Plain-language summary
This study is a prospective, randomized, open-label trial with blinded outcome assessment (PROBE design) designed to evaluate the effects of sodium-glucose cotransporter-2 (SGLT2) inhibitor therapy on cognitive function in adults with type 2 diabetes mellitus (T2D). A total of 200 participants aged 50 years or older with T2D of at least five years' duration and HbA1c ≤8.5% will be randomized in a 1:1 ratio to receive either standard diabetes care plus an SGLT2 inhibitor or standard diabetes care without an SGLT2 inhibitor. Participants will be followed for 12 months.
The primary objective is to compare changes in executive cognitive function between the two treatment groups using a composite cognitive outcome derived from standardized neuropsychological tests. Secondary objectives include assessment of global cognitive function, glycaemic variability measured by continuous glucose monitoring, metabolic control, circulating biomarkers of neurodegeneration and inflammation, functional status, and treatment safety. Baseline brain magnetic resonance imaging (MRI), APOE genotyping, frailty status, sleep quality, psychological well-being, and physical activity will be evaluated as potential modifiers of cognitive outcomes and treatment response.
The study is intended to provide prospective evidence regarding the association between SGLT2 inhibitor therapy and cognitive outcomes in adults with T2D while exploring the metabolic, neurodegenerative, and behavioural factors that may contribute to cognitive changes over time.
Who can participate
Age range
50 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:
* adults aged 50 years or older.
* diagnosis of type 2 diabetes mellitus according to current American Diabetes - - association (ADA) diagnostic criteria.
* duration of type 2 diabetes mellitus of at least 5 years.
* glycated haemoglobin (HbA1c) ≤8.5% (≤69 mmol/mol) at screening.
* estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73 m².
* stable glucose-lowering therapy for at least 3 months before enrolment.
* able to complete neuropsychological assessments and all study procedures.
* willing and able to wear a continuous glucose monitoring (CGM) sensor and a physical activity monitor.
* able to provide written informed consent.
Exclusion Criteria:
* previous or current treatment with a sodium-glucose cotransporter-2 (SGLT2) inhibitor.
* Montreal Cognitive Assessment (MoCA) score \<20 at screening.
* diagnosis of dementia or another major neurocognitive disorder.
* history of stroke or transient ischaemic attack within the previous 6 months.
* Parkinson's disease, multiple sclerosis, epilepsy, or another major neurological disorder affecting cognitive function.
* severe psychiatric illness likely to interfere with study participation or cognitive assessment.
* estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m².
* history of diabetic ketoacidosis.
* recurrent urinary tract infections (≥3 episodes during the previous year).
* contraindication to magnetic resonance imaging (MRI).
* pregnancy, breastfeeding, or planned pregnancy during…
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.