Blood PressureSALTNCT06007157
Sodium Glucose Cotransporter-2 Inhibitors and Salt-sensitivity in Type 2 Diabetes
A study testing Hypersodic/Hyposodic diet in people with Blood Pressure and Salt; Excess, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
Trial summary
The goal of this interventional study is to test whether sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce the effects of high dietary sodium intake in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Blood Pressure, Salt; Excess, Diabete Type 2
- What is being tested?
- Hypersodic/Hyposodic diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-65 years;
- both males and females;
- type 2 diabetes.
Who cannot join
- type 1 diabetes;
- insulin treatment;
- uncontrolled hypertension (SBP > 160 mmHg and/or DBP >95 mmHg);
- pregnancy;
- other acute or chronic conditions influencing blood pressure and glucose metabolism.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria Pisana
Pisa, PI, 56127
Andrea Natali, MD, +39050992814, andrea.natali@med.unipi.it
Andrea Natali, Professor
About this study
Official title: Effects of Sodium Glucose Cotransporter-2 Inhibitors on Salt-sensitivity in Patients With Type 2 Diabetes
The goal of this interventional study is to test whether sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce the effects of high dietary sodium intake in patients with type 2 diabetes.
Participants will undergo a dietary intervention consisting of a week of high-sodium diet, followed by a week of low-sodium diet. At the end of each week the patients will undergo:
Read more
- 24-h ambulatory blood pressure measurement;
- 24-h urine collection;
- bioimpedance analysis for body composition determination;
- blood and urine tests.
The study will compare patients treated with SGLT2i and patients not treated with SGLT2i to test whether the treatment reduces the effects of high sodium intake on blood pressure, body composition and biochemical variables.
- Conditions
- Blood Pressure, Salt; Excess, Diabete Type 2
- Being tested
- Hypersodic/Hyposodic diet
- Keywords
- Salt sensitivity, Sodium glucose cotransporter 2 inhibitors, Type 2 Diabetes, Blood Pressure
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypersodic/Hyposodic dietBehavioural
Participants will undergo a dietary intervention consisting of a week of high-sodium diet (4800 mg/day), followed by a week of low-sodium diet (1200 mg/day).
| Study group | Role | What they receive |
|---|---|---|
| SGLT2i-treated patients | Experimental | Not described Receives: Behavioral: Hypersodic/Hyposodic diet |
| Non SGLT2i-treated patients | Active comparator | Not described Receives: Behavioral: Hypersodic/Hyposodic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour Blood Pressure
Systolic and diastolic blood pressure will be measured by 24-h ambulatory blood pressure monitoring
Measured: 2 weeks
Secondary outcomes (2)
Sodium excretion
24-hour sodium excretion will be measured by urine collection
Measured: 2 weeks
Hydration state
Hydration state with extra- and intracellular water estimation will be measured by bioimpedance
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Mar 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Collaborators
- European Foundation for the Study of Diabetes
- Responsible party
- Principal investigator, Andrea Natali, Azienda Ospedaliero, Universitaria Pisana
- Investigators
- Andrea Natali, Principal investigator, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007157
- Sponsor's protocol ID
- SALT
- Acronym
- SALT
- Status last verified
- Aug 2023
- First submitted
- 18 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared with other researchers only upon reasonable request to the PI
Publications
Chiriaco M, Trico D, Sacchetta L, Nesti L, Cimbalo N, Santoni L, Gallo S, Baldi S, Scozzaro T, Giannoni A, Natali A. SGLT2 inhibitors reduce the salt sensitivity of blood pressure in type 2 diabetes via enhanced postprandial natriuresis. Cardiovasc Diabetol. 2026 Feb 24;25(1):104. doi: 10.1186/s12933-026-03095-2.
PubMed 41736122
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sodium Glucose Cotransporter-2 Inhibitors on Salt-sensitivity in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06007157
- Acronym / sponsor ID
- SALT / SALT
- Conditions
- Blood Pressure, Salt; Excess, Diabete Type 2
- Keywords
- Salt sensitivity, Sodium glucose cotransporter 2 inhibitors, Type 2 Diabetes, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Collaborators
- European Foundation for the Study of Diabetes
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 23 Aug 2023 (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 goal of this interventional study is to test whether sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce the effects of high dietary sodium intake in patients with type 2 diabetes.
Participants will undergo a dietary intervention consisting of a week of high-sodium diet, followed by a week of low-sodium diet. At the end of each week the patients will undergo:
- 24-h ambulatory blood pressure measurement;
- 24-h urine collection;
- bioimpedance analysis for body composition determination;
- blood and urine tests.
The study will compare patients treated with SGLT2i and patients not treated with SGLT2i to test whether the treatment reduces the effects of high sodium intake on blood pressure, body composition and biochemical variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGLT2i-treated patients | Experimental | Behavioral: Hypersodic/Hyposodic diet |
| Non SGLT2i-treated patients | Active comparator | Behavioral: Hypersodic/Hyposodic diet |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18-65 years;
- both males and females;
- type 2 diabetes.
Key exclusion criteria (5 listed)
- type 1 diabetes;
- insulin treatment;
- uncontrolled hypertension (SBP > 160 mmHg and/or DBP >95 mmHg);
- pregnancy;
- other acute or chronic conditions influencing blood pressure and glucose metabolism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypersodic/Hyposodic dietParticipants will undergo a dietary intervention consisting of a week of high-sodium diet (4800 mg/day), followed by a week of low-sodium diet (1200 mg/day). | Behavioural | Non SGLT2i-treated patients, SGLT2i-treated patients |
Primary outcome
24-hour Blood Pressure
Time frame: 2 weeks
Systolic and diastolic blood pressure will be measured by 24-h ambulatory blood pressure monitoring
2 secondary outcomes
Sodium excretion
Time frame: 2 weeks
Hydration state
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Derived from this study: PubMed 41736122Chiriaco M, Trico D, Sacchetta L, Nesti L, Cimbalo N, Santoni L, Gallo S, Baldi S, Scozzaro T, Giannoni A, Natali A. SGLT2 inhibitors reduce the salt sensitivity of blood pressure in type 2 diabetes via enhanced postprandial natriuresis. Cardiovasc Diabetol. 2026 Feb 24;25(1):104. doi: 10.1186/s12933-026-03095-2.
- Individual participant dataSharing planned: No. IPD will be shared with other researchers only upon reasonable request to the PI
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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. This study is not recruiting at the moment.
Andrea Natali principal investigator
Azienda Ospedaliero, Universitaria Pisana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypersodic/Hyposodic diet in people with Blood Pressure and Salt; Excess, run by Azienda Ospedaliero, Universitaria Pisana 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 24 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Natali (+050992814, andrea.natali@unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour Blood Pressure (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06007157, which also lists 1 linked publication.
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 24 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.