Recruiting NCT07119424
Multidisciplinary Dissection of Renal and Metabolic Effects of Glyfozines on Elderly Patients: From Molecular Aspects to Clinical Indications
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Elderly Patients (>65 Years), Diabetes (DM), Heart Disease, Renal Diseases. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Primary outcome measures
- Patient health status prior and after 6 months of SGLT2i therapy through Frailty Index variation (FI) [Time frame: From enrollment to 6 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Current or previous use of SGLT2i;
- Inability to sign the informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
Italy · 1 center
- San Raffaele Hospital — Milan
Identifiers
NCT: NCT07119424 · PNRR-MCNT2-2023-12377474