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

N/ARecruitingNCT07119424

Chiara Lanzani300 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

300

Conditions

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

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Central Contacts

Chiara Livia Lanzani, professor

CONTACT

00390226438131 lanzani.chiara@hsr.it

Federica Guerra, Dr