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

NCT06007157 | Unknown

• 1 other identifier: SALT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; Salt; Excess; Diabete Type 2

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 24-hour Blood Pressure

  Systolic and diastolic blood pressure will be measured by 24-h ambulatory blood pressure monitoring

  2 weeks

Secondary Outcomes (2)

• Sodium excretion

  2 weeks

• Hydration state

  2 weeks

Study Arms (2)

SGLT2i-treated patients

EXPERIMENTAL

Behavioral: Hypersodic/Hyposodic diet

Non SGLT2i-treated patients

ACTIVE COMPARATOR

Behavioral: Hypersodic/Hyposodic diet

Interventions

Hypersodic/Hyposodic diet BEHAVIORAL

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).

Non SGLT2i-treated patients; SGLT2i-treated patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-65 years;
• both males and females;
• type 2 diabetes.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead
• European Foundation for the Study of Diabetes: collaborator

Study Sites (1)

Azienda Ospedaliero-Universitaria Pisana

Pisa, PI, 56127, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Andrea Natali

  Azienda Ospedaliero, Universitaria Pisana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Natali

CONTACT

+050992814; andrea.natali@unipi.it

Martina Chiriacò

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Nutrition

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 23, 2023
• Study Start: March 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: March 1, 2025
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)