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

Sponsor

Azienda Ospedaliero, Universitaria Pisana (Other)

Overall Status

Recruiting

CT.gov ID

NCT06007157

Collaborator

European Foundation for the Study of Diabetes (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Pressure Salt; Excess Diabete Type 2	Behavioral: Hypersodic/Hyposodic diet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SGLT2i-treated patients	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).
Active Comparator: Non SGLT2i-treated patients	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).

Arm

Intervention/Treatment

Experimental: SGLT2i-treated patients

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).

Active Comparator: Non SGLT2i-treated patients

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).

Outcome Measures

Primary Outcome Measures

24-hour Blood Pressure [2 weeks]
Systolic and diastolic blood pressure will be measured by 24-h ambulatory blood pressure monitoring

Secondary Outcome Measures

Sodium excretion [2 weeks]
24-hour sodium excretion will be measured by urine collection
Hydration state [2 weeks]
Hydration state with extra- and intracellular water estimation will be measured by bioimpedance

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.