How SGLT2 inhibitors affect kidneys and metabolism in people over 65

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• San Raffaele Hospital
  Milan, Milan, Italy Recruiting

Study contacts

• Study coordinator: Chiara Livia Lanzani, professor
• Email: lanzani.chiara@hsr.it
• Phone: 00390226438131

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.