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

Not Applicable

Recruiting

• Conditions: Diabete Type 2; Salt; Excess; Blood Pressure
• Interventions: Behavioral: Hypersodic/Hyposodic diet

• Registration Number: NCT06007157
• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-01
• Status Verified: 2023-08
• Study First Submitted: 2023-08-18
• Study First Submitted QC: 2023-08-18
• Study First Posted: 2023-08-23
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-08-24
• Primary Completion: 2024-08-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SGLT2i-treated patients	Hypersodic/Hyposodic diet	-
Non SGLT2i-treated patients	Hypersodic/Hyposodic diet	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria Pisana; 🇮🇹 Pisa, PI, Italy