NCT06007157

Sodium Glucose Cotransporter-2 Inhibitors and Salt-sensitivity in Type 2 Diabetes

Effects of Sodium Glucose Cotransporter-2 Inhibitors on Salt-sensitivity in Patients With Type 2 Diabetes

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Azienda Ospedaliero, Universitaria Pisana · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Hypersodic/Hyposodic diet	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).

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-08-01
• Completion: 2025-03-01
• First posted: 2023-08-23
• Last updated: 2023-08-24

Locations

1 site across 1 country: Italy