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

Blood Pressure Clinical Trial

— SALT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06007157
• Other study ID #: SALT
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: August 2023
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: Andrea Natali
• Phone: +050992814
• Email: andrea.natali[@]unipi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure
• Diabete Type 2
• Diabetes Mellitus, Type 2
• Hypersensitivity
• Salt; Excess

Intervention

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).

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria Pisana	Pisa	PI

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Pisana	European Foundation for the Study of Diabetes

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour Blood Pressure	Systolic and diastolic blood pressure will be measured by 24-h ambulatory blood pressure monitoring	2 weeks
Secondary	Sodium excretion	24-hour sodium excretion will be measured by urine collection	2 weeks
Secondary	Hydration state	Hydration state with extra- and intracellular water estimation will be measured by bioimpedance	2 weeks