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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorChiara Lanzani

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Current or previous use of SGLT2i;

Inability to sign the informed consent.

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 1 trial group
Group A: Subjects with Nephrological, Diabetologic, Cardiological and Internal diseases

Trial outcomes

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

Time frame
From enrollment to 6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chiara Lanzani

Lead sponsor

Ospedale San Raffaele

Sponsor institution