NCT07694596Active, not recruiting
SGLT2 Inhibitors and Cognitive Function in Adults With Type 2 Diabetes (SaveMinD)
Integrative Genetic, Molecular and Behavioural Determinants of Cognitive Decline in Type 2 Diabetes: SGLT2 Inhibitors as a Model for Secondary and Tertiary Prevention (SaveMinD)
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 28 Jun 2026
- Start date
- Jun 2026
- Primary completion date
- Apr 2028
- Lead sponsor
- University of Primorska
- Diseases
- Type 2 diabetes
- NCT number
- NCT07694596
What you commit to
- Study type: Interventional
- Planned participants: 200
- From Jun 2026 to the primary completion date, Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- history of stroke or transient ischaemic attack within the previous 6 months.
- recurrent urinary tract infections (≥3 episodes during the previous year).
- participation in another interventional clinical trial within the previous 30 days.
Other illness
- diagnosis of dementia or another major neurocognitive disorder.
- 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.
- history of diabetic ketoacidosis.
- active malignancy requiring systemic treatment (except adequately treated non-melanoma skin cancer).
- moderate or severe hepatic impairment (Child-Pugh Class B or C).
- presence of an established indication for mandatory SGLT2 inhibitor therapy according to current international clinical practice guidelines (e.g., symptomatic heart failure or chronic kidney disease).
- any medical condition that, in the opinion of the investigator, could compromise participant safety, adherence to the protocol, or interpretation of study results.
Lab values
- previous or current treatment with a sodium-glucose cotransporter-2 (SGLT2) inhibitor.
- estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m².
Other
- Montreal Cognitive Assessment (MoCA) score \<20 at screening.
- contraindication to magnetic resonance imaging (MRI).
- pregnancy, breastfeeding, or planned pregnancy during the study period.
- alcohol or substance abuse likely to interfere with study participation.
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Health Center Coordinator of this site? Confirm its status | Koper | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.