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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Disease; Diabetes (DM); Internal Disease; Elderly Patients (>65 Years); Renal Diseases

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Chiara Livia Lanzani, professor; Phone Number: 00390226438131; Email: lanzani.chiara@hsr.it
• Study Contact Backup: Name: Federica Guerra, Dr; Phone Number: 00390226438131; Email: guerra.federica@hsr.it

Study Locations

• Italy
  • Milan, Italy, 20132
    • Recruiting
    • San Raffaele Hospital
    • Contact: Chiara Livia Lanzani, professor; Phone Number: 00390226438131; Email: lanzani.chiara@hsr.it
    • Principal Investigator: Chiara Livia CLL Lanzani, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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. Patients must be enrolled also in MED-Cli e MED-Mol studies by signing both the MED-Cli e MED-Mol informed consents.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient health status prior and after 6 months of SGLT2i therapy through Frailty Index variation (FI)	Patient health status prior and after 6 months of SGLT2i therapy through Frailty Index variation (FI). The FI is score measured by comparing the ratio of health deficits present within an individual to possible health deficits, using a pre-specified list of 30 or more deficits. Deficits included in the model will be collected during the visit trough questionnaires and clinical and biochemical evaluation	From enrollment to 6 months

Collaborators and Investigators

• Sponsor: Chiara Lanzani

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: July 1, 2025
• First Submitted That Met QC Criteria: August 5, 2025
• First Posted (Actual): August 13, 2025

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Heart Diseases; Diabetes Mellitus
• Other Study ID Numbers: PNRR-MCNT2-2023-12377474

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No