Interventional Recruiting
NCT06007157 on ClinicalTrials.gov
Sodium Glucose Cotransporter-2 Inhibitors and Salt-sensitivity in Type 2 Diabetes
Official title: Effects of Sodium Glucose Cotransporter-2 Inhibitors on Salt-sensitivity in Patients With Type 2 Diabetes
- Sponsor: Azienda Ospedaliera Universitaria Pisana
- Collaborators: European Foundation for the Study of Diabetes
- Enrollment: 30 (Estimated)
- Study start: 2023-03-01 (Actual)
- Primary completion: 2024-08-01 (Estimated)
- Study completion: 2025-03-01 (Estimated)
- Allocation: Non-Randomized
- InterventionModel: Parallel
- Masking: Single (Outcomes Assessor)
- PrimaryPurpose: Treatment
Brief 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.
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.
Conditions
- Blood Pressure
- Salt; Excess
- Diabete Type 2
Intervention / Treatment
- Behavioral: Hypersodic/Hyposodic diet
Primary Outcome Measures
-
24-hour Blood Pressure
(2 weeks)
Systolic and diastolic blood pressure will be measured by 24-h ambulatory blood pressure monitoring
Countries
Italy
Locations and Investigators
-
Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy (Recruiting)
- Andrea Natali, MD
- Andrea Natali, Professor (Principal Investigator)
Study Officials
- Andrea Natali (Principal Investigator) — Azienda Ospedaliero, Universitaria Pisana