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

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.

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

Conditions
-----------------
Blood Pressure, Salt; Excess, Diabete Type 2

Intervention / Treatment
-----------------
* Behavioral: Hypersodic/Hyposodic diet


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SGLT2i-treated patients<br> | Behavioral: Hypersodic/Hyposodic diet<br>* 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).<br>|
| Active Comparator: Non SGLT2i-treated patients<br> | Behavioral: Hypersodic/Hyposodic diet<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Salt sensitivity, Sodium glucose cotransporter 2 inhibitors, Type 2 Diabetes, Blood Pressure