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

NCT07119424 | Recruiting

• 1 other identifier: PNRR-MCNT2-2023-12377474
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study;
• Patients must be enrolled also in MED-Cli e MED-Mol studies by signing both the MED-Cli e MED-Mol informed consents.
• 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;
• Age ≥65 years;
• Participant has not yet started the prescribed SGLT2i therapy;
• Participant has at least one clinical indication for SGLT2i use according to clinical practice guidelines.

You may not qualify if:

• Current or previous use of SGLT2i;
• Inability to sign the informed consent.

Sponsors & Collaborators

• Chiara Lanzani: lead

Study Sites (1)

San Raffaele Hospital

Milan, Milan, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Heart Diseases; Kidney Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Chiara Livia Lanzani, professor

CONTACT

00390226438131; lanzani.chiara@hsr.it

Federica Guerra, Dr

CONTACT

00390226438131; guerra.federica@hsr.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: August 13, 2025
• Study Start: February 14, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

IT (1)