Effects of Sodium Glucose Cotransporter-2 Inhibitors on Salt-sensitivity in Patients With Type 2 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- 24-hour Blood Pressure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age 18-65 years;
- •both males and females;
- •type 2 diabetes.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
24-hour Blood Pressure
Time Frame: 2 weeks
Systolic and diastolic blood pressure will be measured by 24-h ambulatory blood pressure monitoring
Secondary Outcomes
- Sodium excretion(2 weeks)
- Hydration state(2 weeks)
Investigators
Andrea Natali
Full Professor of Nutrition
Azienda Ospedaliero, Universitaria Pisana