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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06007157

Acronym

SALT

Enrollment

Registered

2023-08-23

Start date

2023-03-01

Completion date

2025-03-01

Last updated

2023-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Diabete Type 2, Salt; Excess

Keywords

Salt sensitivity, Sodium glucose cotransporter 2 inhibitors, Type 2 Diabetes, Blood Pressure

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.

Interventions

BEHAVIORALHypersodic/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).

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
24-hour Blood Pressure	2 weeks	Systolic and diastolic blood pressure will be measured by 24-h ambulatory blood pressure monitoring

Secondary

Measure	Time frame	Description
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

Countries

Italy

Contacts

Primary ContactAndrea Natali

andrea.natali@unipi.it+050992814

Backup ContactMartina Chiriacò

martina.chiriaco@spec-med.unipi.it+050993640

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026