How SGLT2 inhibitors affect kidneys and metabolism in people over 65
Multidisciplinary Dissection of Renal and Metabolic Effects of Glyfozines on Elderly Patients: From Molecular Aspects to Clinical Indications
This project will test whether starting SGLT2 inhibitor treatment changes clinical and lab measures in people aged 65 and older with diabetes, heart disease, or kidney problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Ospedale San Raffaele Academic / other |
| Locations | 1 site (Milan, Milan) |
| Trial ID | NCT07119424 on ClinicalTrials.gov |
What this trial studies
This is an observational cohort of patients aged 65 or older who are prescribed SGLT2 inhibitors as part of routine care at San Raffaele Hospital and who have not yet started the medication. The study will combine clinical records, biochemical and biological data from participants enrolled also in the MED-Cli and MED-Mol protocols. Advanced Bayesian statistical methods will be used to model relationships between baseline risk factors and subsequent renal and metabolic outcomes after treatment. Treatment decisions are made independently by clinicians and the study does not dictate prescribing.
Who should consider this trial
Good fit: Ideal candidates are adults aged 65 or older who have at least one guideline indication for SGLT2 inhibitors, have not yet started the drug, can give informed consent, and agree to enroll in the related MED-Cli and MED-Mol protocols.
Not a fit: Patients already taking an SGLT2 inhibitor or those unable to provide informed consent would not be eligible and thus would not benefit from participation in this project.
Why it matters
Potential benefit: If successful, the project could clarify which elderly patients are most likely to experience renal or metabolic benefits or risks from SGLT2 inhibitors and help guide safer prescribing.
How similar studies have performed: Large clinical trials have shown cardiovascular and renal benefits of SGLT2 inhibitors in broad populations, but combining detailed molecular data with Bayesian modeling in an elderly cohort is a more novel observational approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participant is willing and able to give informed consent for participation in the study; 2. Patients must be enrolled also in MED-Cli e MED-Mol studies by signing both the MED-Cli e MED-Mol informed consents. 3. The medical product is the standard of care for the patient and has been prescribed according to clinical practice and independent of the present study; 4. Age ≥65 years; 5. Participant has not yet started the prescribed SGLT2i therapy; 6. Participant has at least one clinical indication for SGLT2i use according to clinical practice guidelines. Exclusion Criteria: 1. Current or previous use of SGLT2i; 2. Inability to sign the informed consent.
Where this trial is running
Milan, Milan
- San Raffaele Hospital — Milan, Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Chiara Livia Lanzani, professor
- Email: lanzani.chiara@hsr.it
- Phone: 00390226438131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.