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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07119424

Enrollment

300

Registered

2025-08-13

Start date

2025-02-14

Completion date

2027-02-28

Last updated

2025-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Patient health status prior and after 6 months of SGLT2i therapy through Frailty Index variation (FI)	From enrollment to 6 months	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

Countries

Italy

Contacts

Primary ContactChiara Livia Lanzani, professor

lanzani.chiara@hsr.it00390226438131

Backup ContactFederica Guerra, Dr

guerra.federica@hsr.it00390226438131

Outcome results