Multidisciplinary Dissection of Renal and Metabolic Effects of Glyfozines on Elderly Patients: From Molecular Aspects to Clinical Indications

NCT ID: NCT07119424

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-14
• Study Completion Date: 2027-02-28

Brief Summary

The project aims to study the impact of SGLT2i therapy on clinical and biochemical aspects. in elderly. The project will combine different types of data, such as clinical and biological information, and will use advanced Bayesian statistical methods to understand the relationship between risk factors and patient outcomes following treatment with SGLT2 inhibitors.

Conditions

Elderly Patients (>65 Years); Diabetes (DM); Heart Disease; Renal Diseases; Internal Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Subjects with Nephrological, Diabetologic, Cardiological and Internal diseases

Patients aged ≥65 years, either females or males, who have just been prescribed, in accordance with clinical practice and due to clinical reasons independent of the study, a SGLT2i for any clinical indication for SGLT2i use, who have not yet started SGLT2i therapy, and yet not under SGLT2i treatment.

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiara Lanzani

OTHER

Sponsor Role: lead

Responsible Party

Chiara Lanzani

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

San Raffaele Hospital

Milan, Milan, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Chiara Livia Lanzani, professor

Role: CONTACT

lanzani.chiara@hsr.it

00390226438131

Federica Guerra, Dr

Role: CONTACT

guerra.federica@hsr.it

00390226438131

Facility Contacts

Chiara Livia Lanzani, professor

Role: primary

lanzani.chiara@hsr.it

00390226438131

Other Identifiers

PNRR-MCNT2-2023-12377474

Identifier Type: -

Identifier Source: org_study_id