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| Name | Class |
|---|---|
| European Foundation for the Study of Diabetes | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGLT2i-treated patients | Experimental |
| |
| Non SGLT2i-treated patients | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypersodic/Hyposodic diet | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour Blood Pressure | Systolic and diastolic blood pressure will be measured by 24-h ambulatory blood pressure monitoring | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sodium excretion | 24-hour sodium excretion will be measured by urine collection | 2 weeks |
| Hydration state | Hydration state with extra- and intracellular water estimation will be measured by bioimpedance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Natali | Contact | +050992814 | andrea.natali@unipi.it | |
| Martina Chiriacò | Contact | +050993640 | martina.chiriaco@spec-med.unipi.it |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Natali | Azienda Ospedaliero, Universitaria Pisana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero-Universitaria Pisana | Recruiting | Pisa | PI | 56127 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41736122 | Derived | 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. |
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IPD will be shared with other researchers only upon reasonable request to the PI
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 2 weeks |
| D004700 | Endocrine System Diseases |