Elderly Patients (>65 Years)NCT07119424
Multidisciplinary Dissection of Renal and Metabolic Effects of Glyfozines on Elderly Patients: From Molecular Aspects to Clinical Indications
An observational study of Elderly Patients (>65 Years) and Diabetes (DM), run by Chiara Lanzani at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Elderly Patients (>65 Years), Diabetes (DM), Heart Disease
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 14 Feb 2025to Feb 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Current or previous use of SGLT2i;
- Inability to sign the informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
San Raffaele Hospital
Milan, Milan, 20132
Chiara Livia Lanzani, professor, 00390226438131, lanzani.chiara@hsr.it
Chiara Livia CLL Lanzani, professor
About this study
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
- Medical subject headings
- Diabetes Mellitus, Heart Diseases, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start14 Feb 2025
- Primary completionNov 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly Patients (>65 Years)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Chiara Lanzani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chiara Lanzani, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119424
- Sponsor's protocol ID
- PNRR-MCNT2-2023-12377474
- Status last verified
- Aug 2025
- First submitted
- 1 Jul 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Dissection of Renal and Metabolic Effects of Glyfozines on Elderly Patients: From Molecular Aspects to Clinical Indications
- ClinicalTrials.gov ID
- NCT07119424
- Acronym / sponsor ID
- PNRR-MCNT2-2023-12377474
- Conditions
- Elderly Patients (>65 Years), Diabetes (DM), Heart Disease, Renal Diseases, Internal Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chiara LanzaniUniversity, hospital or other
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (2 listed)
- Current or previous use of SGLT2i;
- Inability to sign the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient health status prior and after 6 months of SGLT2i therapy through Frailty Index variation (FI)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elderly Patients (>65 Years) and Diabetes (DM), run by Chiara Lanzani at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiara Livia Lanzani, professor (00390226438131, lanzani.chiara@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient health status prior and after 6 months of SGLT2i therapy through Frailty Index variation (FI) (time frame: From enrollment to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.